Michael Pollock: Good afternoon, everyone. Welcome to the first ever patient-focused medical product development meeting to explore depression. My name is Michael Pollock. I’m the chief executive officer for the Depression and Bipolar Support Alliance, also known as DBSA. On behalf of the board of directors and the staff who have joined us here today, we are grateful to all the peers and their supporters who have traveled to Silver Spring to share their perspectives and to those who are participating virtually through our live webcasts. DBSA has a vision to transform the definition of wellness throughout the entire healthcare ecosystem, to achieve treatment outcomes that reflect what’s important to people who live with mood disorders.

Today’s meeting is a major step towards realizing that goal. We are grateful to FDA staff, medical product developers, and researchers who are in attendance. Over the next four hours through polling and guided discussion, peers and their supporters will be sharing the impact depression has had on their life and the demands it can place on their whole health, as well as identifying current treatment options that are making a difference and sharing their personal outcome goals. It is our hope that by better understanding the impacts, burden on whole health, identified treatment options that are working, and treatment outcomes sought by peers, we will highlight the need for continued innovation in research and development among the industry and with regulators.

Before we begin, I want to take a moment to thank our partners and our sponsors who made today’s meeting possible, and they are listed here on the screen. Please join me in giving them a round of applause.

Today’s meeting is facilitated by Jane Axelrod. With more than 25 years’ experience at the FDA, Jane is now a consultant focused on regulatory policy, oversight, and compliance issues affecting the FDA. As the FDA’s Center for Drug Evaluation and Research associate director for policy and director of the Office of Regulatory Policy, Jane led multidisciplinary teams of scientists, technical experts, and attorneys in addressing complex, regulatory policy issues. She was a member of the FDA’s negotiating team for four reauthorizations of the

● ● ● ● Prescription Drug User Fee Act, or PDUFA, including PDUFA V, in which the patient-focused drug development initiative, of which this meeting is an example, originated. Join me in welcoming Jane.

Jane Axelrod: Thank you. I’m very pleased to be here today—help facilitate this important meeting, to hear from you about what’s important in living with and managing depression. Before we get started I’m going to go over a couple of housekeeping duties. The agenda for the meeting is in your program. As you’ll see from the agenda we’re going to be taking about a 15-minute break at 2:30, but if you need to get up and walk and go outside, feel free to do that. The restrooms are down the hall. Right outside this door is one of them, and around the corner by the registration desk is the other.

To begin the meeting I’d like to start by introducing Dr. Mitchell Mathis and invite him to give some opening remarks from FDA’s perspective. For six years, Dr. Mathis has directed the Division of Psychiatry Products in FDA Center for Drug Evaluation and Research with experience developing efficient clinical trial designs and leading a team of scientists and physicians to regulate US psychiatric drug development. He trained in psychiatry and family medicine after graduating from the Uniformed Services University of the Health Sciences. He’s a veteran of the US Air Force and Public Health Service.

Dr. Mathis: Thank you, Jane—Jane says, my name is Mitch Mathis, and I run the Division of Psychiatry Products, where they approve drugs for psychiatric indication. Very happy to be here today to tell you how we have incorporated the patient voice into the business that we do in the division, and what we’ve learned from meetings like this and what we hope to learn from this one. I think the government actually has a lot of good ideas—a few are great ideas. One of the great ideas in my view is when we decided along with industry, along with academia to make what we do as clinically relevant as we possibly can.

When we develop drugs, it’s an aseptic environment. It’s not reflective necessarily of exactly the patients we treat, but it’s the best we can do. We try to hold everything steady. We move one thing at a time, and then we see if we can statistically see a difference between drug and placebo a couple of times. In clinical practice that’s not what we do, and I think PFDD groups are moving that sterile environment into more of what we do in clinical practice. I’m a clinician. I’ve been taking care of patients for a long, long time. A lot of the people I work with at FDA also maintain patient populations that they’ve been taking care of a long time.

Psychiatrists are a little different than other physicians. Maybe we’re similar to primary care, but a patient can come see a psychiatrist for many, many years.

● ● ● ● The reason is—because unlike other medical conditions where you might have a drug that can cure the patient or a procedure that can fix them and they don’t need the doctor anymore, we don’t have that yet. We have—our medications and our therapy reduce symptoms. They don’t cure anything, and we’re pushing of course towards that and one day we will get there. I hope that today I get to see in the mean time we have to work with meds that treat patients symptomatically.

When I take care of patients in my office—I’ve been taking care of them for quite a long time and I talk to them. I know them and I know what parts of depression matter to them. I think that that relationship of knowing the patient is at least as potent as the medications that we’re using. When you combine that, you get the best result, in my view. Patient-focused drug development does this at a level that can have some regulatory significance. We come here to learn and to unlearn, if there’s something we need to unlearn, and to take that information back and to do a better job at regulating medications. The point is that the reason this is one of my favorite things to do is because it’s very much like clinical practice and I think that’s what makes it the most useful.

Phyllis asked me to give a couple of examples of incorporating the patient voice and to psychiatric drug development, so I brought two examples. I only have 10 minutes, sorry. One was a PFD meeting—patient-focused drug development meeting much like this, for patients with autism or autism spectrum disorders. I learned a great deal from that meeting. I’ve been taking care of patients with ASD for a long time, but it’s a different dynamic to put a bunch of people struggling with the disease in a room with the regulators to tell us what we’re doing right and what we’re doing wrong—what they need. They support each other, a different attitude comes out, and that was extremely productive for me and I’ll give you a couple of examples.

One thing I knew already but it solidified in my mind and something that I had to unlearn. Almost universally the patients with ASD and autism said that the thing that bothered them the most was the lack of social interaction with other human beings. That’s a diagnostic criteria. Everybody knows that. It should probably be a drug target, but I didn’t realize that most people would say that that was on their top three list of things they need to get fixed. That’s one of the things that they would like new drugs to be developed for.

When we learn something like that, when you see it so universally and you believe it, what it means to me as a regulator is that now I can understand the patient group better in the sense that we don’t have a drug, as I said, that will cure ASD, but if we had a drug that would increase the social interaction and allow people to engage other human beings, that would be a legitimate drug

● ● ● ● target because it’s obviously important to patients. I think that’s the point. If it’s important to patients and it’s clinically relevant, then it should be considered a legitimate drug target.

One of the things I had to unlearn—patients with ASD, as many of you might know, self stimulate as a way to dissipate the psychic anxiety, one patient told me. They have repetitive body movements. They oftentimes will rock or flap their hands or move their head or their eyes, and we as external observers who are designing clinical trials I know have looked at that and said, “If we find a medication that might reduce that self-stimming, that would be a good move, because that’s obviously distressing to the patient.”

Couldn’t have been further off the mark from the PFD meeting. There was one lady who said, “Please keep your hands off my stimming. That’s what makes me feel better, and in fact, when I’m really ill, when I feel really bad, I can’t even muster a good self stimming. So you might be measuring me in my worst state thinking I got better.” That was very eye opening. That means a lot. We wouldn’t have learned that from a textbook. The textbook doesn’t say that. In fact, you learn that when you talk to patients, and again I think that was that group dynamic that brought that out. I hope we get some of that today.

Second example of incorporating the patient voice was the SMDDS. That’s the Symptoms of Major Depressive Disorders Scale. This is a patient-reported outcome which already is incorporating the patient more than other scales. A patient-reported outcome takes what the patient says and puts it on the outcome. A clinician-reported outcome takes what the patient says, runs it through the clinician, and puts it on the outcome as if the clinician might know more about how the patient’s feeling than the patient.

That’s been the standard for a long time, and luckily we have a standard. We’ve been able to actually get some drugs approved with that standard, but it’s very important to know what the patient thinks about their disease. When they come to me in my office, I don’t say, “Let’s do a Hamilton D17 Depression Rating Scale and assess you.” By the time we got that done the appointment would be over. I say, “There’s two things that have been bothering you for the last 10 years. How are we doing on those two things?” That’s because I know the patient. You can’t do that universally when you’re developing drugs. You could probably do a better job in a clinician-reported outcome.

The Critical Path Institute’s Patient-Reported Outcome Consortium qualified or developed this instrument, and FDA along the way—my division, the Division of Psychiatry Products, and the Clinical Outcomes Assessment staff were right there with them. We helped make some decisions that I think sped the process

● ● ● ● along. In the end what we had was a qualified instrument. What a qualified instrument means is that FDA has upfront agreed that it measures what it thinks it measures and that it could be meaningful to patients and with time would likely end up as a primary endpoint, perhaps, and into a patient label. You might take what the patient says, run it through the regulatory machinery with this new instrument, and put it in a label, which is the owner’s manual for the drug, so that everybody knows about it.

I think that’s a real interesting thing. That’s a real nice way to bring the patient voice from the patient into the drug development process. It’s not just psychiatry products. I just want to brag about the Center for Drugs for a little bit. In the Prescription Drug User Fee Act, PDUFA V, we were mandated to have at least 20 PFDD meetings in the first year. We had 24, and that—I’m not telling a big accomplishment to a lot of people, but in a big, bureaucratic place where there’s a lot of work to do and not enough people to do it to do—more than the minimum of anything means only one thing, usually. It’s extremely useful. It’s fundamentally good for drug development, and that, I think, speaks for these PFDD meetings—that that’s the case.

PDUFA VI is ongoing, and we were ordered to develop some guidances on how to inject the patient voice wherever we can, from developing new instruments to designing trials, et cetera. I just read an article this morning that there was some public comment on that, and that’s moving along very well.

In summary, today we’re going to hear from a lot of experts about Major Depressive Disorder, how to treat it. That’s great. I love talking to experts about how to treat depression. What is truly extraordinary about today is going to be that we get to talk to the world’s best experts about what it means to have depression—what it’s like to live with it and what the drugs are doing well, what they’re not doing well, what people need, and those, of course, are the patients who struggle every day with the disease. Those of you who are here will represent those around the US and around the world who have the disease, and it will be very good to hear for you. I look forward to the discussion today, and I’ll hand it back to you.

Jane: Thank you so much, Dr. Mathis. We’re very grateful that you and other FDA staff have taken the time to be with us today, and we hope that you’ll get some very valuable insights out of the meeting.

Facilitator: Gary Sachs is the Associate Clinical Professor in Psychiatry at Harvard Medical School and the Founding Director of the Bipolar Clinic and Research Program at

● ● ● ● Massachusetts General Hospital where he has been in clinical practice since 1990. He has conducted numerous clinical trials of new medications, and has authored more than 200 peer review publications, including several review articles that focus on optimizing treatment outcomes to meet patient’s individual needs. Dr. Sachs serves on DBSA’s Board of Directors and is Co-Chair of DBSA’s Scientific Advisory Board. He is a distinguished fellow of the American Psychiatric Association and is recognized as a top doctor on U.S. News and World Report. Dr. Sachs will present an end users perspective on the development of drugs for depression.

Gary Sachs: Thank you very much. I am not sure who wrote that but I think it might have been my mother. My [inaudible 01:00] following up on that excellent opening is to add this perspective as an end user. When I say end user, of course I am predominantly referring to the patient perspective. I want you to understand that it is also my perspective as a clinician. When I sit alone in a room with the patient and I have to answer questions to determine what is the next step of treatment and I am looking for guidance. I hope we will have better guidance in the future but I want to give you a sense of the end user perspective from where we are now. A few points just to introduce the idea—all of this is going to be reviewed for you, but depression has a staggering impact.

We are all aware of the urgent need for better treatments. Notice it does not just say more treatments, but better treatments. We would all like to have better treatments. We want to be measuring outcomes not because they are easy but because they are meaningful. And, of course, the reason we are all in the room today is to establish this collaboration going forward with all the stakeholders. Unfortunately, the patient voice has been the softest in the room if it is present at all. We would like to see that changed. Let me expand on those points a little bit. This is from [inaudible 02:26] and you are looking at health scores and you can see if you have no chronic condition, maybe the average is pretty good, but it starts to dip down with a lot of common chronic conditions.

If you add depression to those, you can see that they are all substantially reduced but if you were to look at the impact of having any two of those chronic conditions, you can see that there is a huge drop off when depression is part of it. Depression is not a thing apart. It is quite common across the Z states. It is not this pure-bred clinical entity that we see all by itself. It is almost always keeping company with other common conditions. We are all familiar with the FDA’s roadmap. To add an end user perspective, you can see how for each the three panels here, we might add a few things to add to the understanding of Z’s.

The frightening prospective of the recurrence and relapse rates associated with

● ● ● ● depression, and to look at data that would include the past treatment history for patients. Some of these things are relatively easy combined but you will not find them in the literature—to look at the risk benefit ratios, not just by themselves but how they actually impact the way patients or caregivers receive the benefits of their treatment. And of course, we have a lot of emphasis on symptoms of the illness, but we are also very interested in what the well periods are like. Are patients able to thrive? Do we get full life back? One of the other points that is of great concern to us is when we look in the literature, we see the pivotal trials reported, and we see all of these great results, the question is how representative are those results?

[Inaudible 04:38] made that point. Often, the data does not generalize to the treatment seeking population. This is a huge problem, which is also mentioned in developing new and perhaps better clinical assessment—clinical outcome assessment measures. That would be great. We have some but they all need some work. Here is a list of common questions that I get from patients. Obviously, what is the best treatment for me? What drug is likely to get me back to normal, like fast? That is a very good question we do not know the answer to. If I did not get better taking the first drug or Drug X, what are the chances that Drug Y will work for me? We actually do not have any meaningful data about that. Will continuing the medication that got me well keep me well? What would happen if I kept taking it? What would happen if I stopped taking it?

Are there things that patients can do that will increase the likelihood of their response? We actually have precious little data for any of these. This statement, I used to think came from Paul Lever. I think I first heard it at an early NCDEU meeting in Biscayne, but it turns out it is from Edward Deming. In God We Trust. All Others Must Bring Data. At DBSA and increasingly all across advocacy, we embrace this idea of bringing data to the table. We will present a little bit of survey results. I have a cross section of some of the results. The survey that I am going to tell you about today assessed a wellness strategy and the perceived benefit from the treatments that patients get. Here are some good and bad news.

The good news is that patients do a lot of things to try to get better—not just one at a time, but they will often combine medication wellness strategies and various forms of psychotherapy, etc. Unfortunately, the satisfaction is not great. You see that the not effective tends to be about one-quarter to one-third of patients with unipolar or bipolar group. The completely effective is under 30 percent in both groups. We have a lot of unmet need. What happens when patients get these treatments? They are continuously searching for both efficacy and tolerability, but you can see they seldom find it. Did not feel it was

● ● ● ● working sufficiently is two-thirds or so of patients. About half to two-thirds of patients stop for tolerability reasons. So a very common condition is that half the patients are looking for new treatment every three months.

When we look to the literature to say, which of that new treatment should be? We get back to this representativeness issue. This is from [Star D 07:38]. You can see if you divided the sample based on those who would have gotten into a typical efficacy trial versus those who would not, about 80 percent of the patients in Star D would never have made it into a trial that would get FDA review. These are the kinds of patients that are out there seeking treatment. You wonder, does this matter for outcome? You can see in the Blue Line—that is the efficacy sample and getting higher up there means that more people are getting better. Being lower down where the Red Line is, they are not. So a lot of the patients who do not make it in but require treatment, they are not getting as good an outcome even as we would expect from standard clinical trials.

This is another view of a similar kind of issue. It gets back to that new self-report measure that Mitch mentioned in his talk. Here we are talking about the Quids—another kind of outcome measure. There is a clinician-reported version of it and a self-reported version. The top Blue Line is the—I guess it starts out in the middle—is the clinician version and then you see that Middle Line, that is the patient-report version. You can see that even when the severity measure is the same, there is a gap here. There are a number of people who the clinicians are thinking are getting better, where the patients do not perceive themselves as better. We need to account for this, particularly as you can see here, the bigger that gap is, the worse the outcome is overall and the more and more we have people who are getting treatments that they perceive as completely ineffective.

One of the experiences for me when I was Principle Investigator for STEP-BD that was really instructive was NIH in its wisdom required us to conduct fake focus groups and ask clinicians, patients, and family members about the outcome measures we were going to use. This idea of durable recovery, which in STEP-BD required eight consecutive weeks well. You know that no clinical trial has ever used that. All the clinicians we asked thought that was much too stringent. In every patient group and every family group said that is much too short to be meaningful. From our point of view, that meant we got it exactly right. I think outside the room, it means we really got it exactly wrong. We would like to see the bar raised. We would like to see the roadmap include these items. We would want to all encourage better treatment.

I think a big part of that is including patient stakeholders in the process. That is

● ● ● ● why I am glad you are all here. All of you in the room have a role in this. We really want to see some meaningful evidence as quickly as possible. Let us build on what is working and continue this collaboration. Thank you very much.

Facilitator: Thank you very much.

Facilitator: Four panelists this afternoon who will share with the audience the impact of living with depression has had on their life. Thank you all for being willing to share your stories. Our first speaker is Allison Francis Barksdale. Allison?

Allison Francis Barksdale: Thank you. Good afternoon, distinguished guest, DBSA supporters, and my fellow peers. It is a privilege to address you today. And I do want to extend my gratitude, especially to DBSA for this opportunity to share a little bit about my experience and the goals that I have for future product development, have actually entitled my remarks by saying, "We'll be on surviving to thriving." That's my goal.

For me, I've lived with depression or a form of it for more than 25 years. And my illness first presented when I was in my junior year of college, my 20s. And it took 10 years to be able to get a definitive diagnosis and during that time, during that intervening period, it was one of a lot of turmoil. I said, I started feeling those first symptoms when I broke off an engagement to be married and I felt guilty about that. I felt that I had ruined my fiance's life and so I should ruin my life as well.

And I was going to drop out of college but my mother had another plan. And what she did—and God bless her, she didn’t agree with the idea of me dropping out of school, I was a good student. So, instead she sent me to see a psychiatrist and at that point, I started learning about having to a behavioral therapy and other wellness treatments.

But the whole period was a lot of starts and stops in my life. I did graduate from college, I had gotten a scholarship for a master's program to study in France but despite that, I couldn’t handle it. And I didn’t finish the program because while I was in France, I started feeling overwhelmed. I had a sense of fear of terrorism and isolation and that led me to drop out of the program mid-semester and I forfeited my scholarship.

Also during that time, I had seven different jobs in a ten-year period. I also was hospitalized three times. And it wasn’t until that third hospitalization that I was given a diagnosis and was stabilized on medication. Now, I know the triggers

● ● ● ● and the warning signs that I can use to avoid hospitalization. And for me, because of the form of depression that I experience, there's overspending. Maybe I'm talking too much, maybe I am sleeping too much or not sleeping at all. It's just dangerous.

So, I put together a list that I can use to, sort of, check my symptoms and see how I'm feeling. I also had shared that with a few trusted people just in case they notice something. And so far though, I haven’t needed it. So, I have been on the same medication the past 25 years. And I do, I consider myself blessed to be so responsive, especially to one medicine and for so long. Still, there is room for improvement. And I implore product developers to more seriously consider the long-term side effects of medication.

Individuals like me, and was also referenced earlier, who are dependent on medication for the rest of their lives, need greater peace of mind when taking medicine with a long-term. And I do, I take the lead in my treatment. I have a wellness team that includes my medical doctor, my psychiatrist, I see a therapist as well, and I have family members and a very few select people who understand what's going on—really, my key message that I want to share is that people understand, "Yes, I do have a mental-health illness but I am not my diagnosis."

And I would like for people to shift the focus from the diagnosis to the whole person, especially when you're developing patient-centered solutions. Consider the quality of life. And this may surprise you but my definition of quality is really simple. It includes things like, I can get up in the morning, fix my son breakfast, before he goes off to school. Big, big [two 00:05:42].

Also, I am currently working but I am underemployed. You may ask "What is underemployed?" And in my case, it's working for that rate and level below my qualifications. I've held key positions in my life. I've been a general manager of a convention center, a director or strategic development and I've also served as an executive director of a non-profit organization.

That position however was eliminated after I had to take a medical leave of absence that was brought on by stress. So, now instead of really looking for a leadership position, I have decided to create my own, the CEO of my own business which is called Rise Leadership. And this is a professional development company that I started to help women grow as individuals and leaders because my process accepting my illness has also helped me to teach others how to accept themselves just as they are. I like society to start doing that as well.

● ● ● ● But I have a new start-up business and my income is limited therefore so I have to supplement my business and thus the underemployment. I work as a substitute teacher. That is not the best use of my executive MBA but it does help pay the bills. So, I long for the ability to be able to lead without the fear of being overwhelmed by stress. And I do expect that there will be more positive changes happening in my lifetime with wellness options that we don’t have to choose tradeoffs like memory loss, impaired coordination, organ failure or anything like that that is often part of package when you're taking medication long-term.

So again, I am taking the lead in my treatment and I'm asking you to join me in helping to empower others to do the same so that together we will be able to move well beyond surviving to thriving. Thank you.

Facilitator: Thank you so much, Allison. Our next speaker is Shelby Goodrich Eckard (ph).

Shelby Goodrich Eckard: Good afternoon. I just want to first of all, say how grateful I am for this opportunity to speak about this important issue to me. I am a 33-year old, mother of two, who is living with depression but also Polycystic Ovary Syndrome or as it's more commonly known, PCOS.

The diagnosis of PCOS makes my situation more complex because both depression and PCOS have so much stigma attached to them that I feel like it's making it more difficult for my providers to really listen and see me as a whole person and whole treatment plan versus spreading me and dividing me by diagnosis codes and treated in certain parts of my treatment plan. I come from a large family but I have an even larger list of familial history with mental-health conditions.

I lost my aunt who died by suicide when I was 24. Unfortunately, mental-health was not discussed growing up and even after we lost her. So, with my diagnosis of depression, I am more determined than ever to not stay silent about mental- health concerns. And even though I'm proud of being the first in family to really tackle depression as a serious health concern that it is, I still feel a very large disconnect in my treatment.

I feel very frustrated because I feel like all of my providers should be working as a team and communicating. My psychiatrist does not talk to my therapist, my gynecologist does not talk to my psychiatrist. I feel like they should be coming together and treating all of it as one—I'm a whole person, I am not broken down by my diagnosis.

● ● ● ● So, for instance, my psychiatrist will think because my depression symptoms are well-controlled, that his plan is working. But if he called up my therapist and he asked him, he would know that my long-term wellness goals are not being achieved. Because my psychiatrist says I'm well, there are certain mental-health treatment aspects that are no longer deemed necessary and not eligible for insurance reimbursements. So, I missed out on those important aspects of my treatment.

With PCOS, I feel it's important that all my providers be talking because it affects so many different aspects of my health. For an example, if my gynecologist was in touch with my psychiatrist, they would know I'm struggling with depression and I have a history of suicidal ideation. So, my gynecologist would have not tried to prescribe a birth-control medication that has an increased risk of suicidal ideation.

Unfortunately my own health etiquette—and I was aware of that fact but what if I wasn’t informed? Why was I in-charge of connecting the missing links? I don’t think that's right. That's their job. So, with PCOS, being a metabolic and a hormone disorder that affects many systems within my body, I feel that my healthcare should be comprehensive. I feel like my providers are passing the buck and no one wants to take responsibility instead of them just being cohesive together.

Sorry. Excuse me. For instance, my psychiatrist will say, "Well, if you're unhappy with the weight that's associated with PCOS, well, you need to talk to your primary care doctor." Or my gynecologist will say, "I think you need to get your depression under control so back over to the psychiatrist." And then for instance, things that happened where I've been prescribed medications where they actually worsen my depression or my PCOS because of the way the health care system is setup right now, it is not conducive for my health care providers to be communicating easily about me as a whole.

So, I feel frustrated and let down and frankly, more depressed. With none of my clinicians willing to communicate, I feel like that puts me in a position as a patient for being in-charge of making decisions about the tolerable benefits and risk that I'm willing to accept for the treatment of my condition but I don’t have medical knowledge to make and form an educated decision. That should be something that they are taking care of and I don’t think that's right.

With these conditions so interconnected, I feel so frustrated and exhausted, feeling like I'm doing the work trying to connect them together. And with both my conditions being hereditary, I worry about my children, especially my

● ● ● ● daughter who is more likely to have one or both of these conditions. And I just want better for her.

I want her to not only speak openly about our mental health and not being apprehensive to seek treatment but also speak up when she feels that her healthcare team is not working her needs and her end goals or her wellness. I truly believe she can have a better life if clinical trials and research put the patient as a whole first and wasn’t so focused on our separate diagnosis.

Looking back, I wonder if my aunt had PCOS. She had a lot of the symptoms and besides her depression bipolar, she displayed a lot of the symptoms that are common in PCOS and PCOS was not on the forefront back then. It's not even on the forefront, we're working hard to do that though.

I feel like she could have gotten undiagnosed. There's a study that shows women with PCOS are seven times more likely to attempt suicide than others. So, I truly believe that if she had a comprehensive medical team, if she had doctors working together, she had people looking out for her as whole, she may still be here today. That's why it's so important to me to not only do this for her but to do it for my children and for my own health. Thank you.

Facilitator: Thank you so much, Shelby. Our next speaker is Allie Bodac (ph).

Allie Bodac: Hi. Good afternoon. Thank you all so much for taking the time to listen. I just want to clarify that I'm here on behalf of only myself with the hope of inspiring others to voice their concerns, ask questions and become advocates for their own mental-health care. Excluding my immediate circle of supporters, you will all be the first to hear about my experiences with mental-health treatment including psychiatric medication.

I was extremely hesitant to speak about this topic, however I strongly believe in the powerful effects of personal story telling. I began psychiatric treatment for the first time when I was 11. I was a result of early childhood trauma and bullying. I was required to attend individual therapy with a child and adolescent social worker but was not prescribed medication at this time. One day, during a session, I had expressed my anger about my inconsistent living situation. I could sense the therapist's obvious discomfort as if she were walking on eggshells.

Overall, it was difficult for us to develop rapport and I eventually stopped going. Throughout my undergraduate and previous graduate schoolwork, I had developed consistent suicidal ideation. Every day from months on end, I would think about ending my life. And regardless of my mental state, I was fully

● ● ● ● functional, I appeared put together. I was exercising and eating well and I was involved in activities and organizations at school.

Before I was prescribed psychiatric medication, my decline became pretty evident. I was enrolled in a graduate program and my coursework had significantly increased. I felt panic and depressed almost daily. I was isolating from peers and outwardly angry and also physically deteriorating.

However, throughout that time, I felt that asking for help was not really an option. So, instead of asking for help, I fixated on my inability to trust that others would help me and I told myself that I needed to continue fighting on my own. Eventually, I was unable to complete the program. In my early 20s, I started taking psychiatric meds. It was difficult to be compliant mostly because my peers kept asking me how long it would be before I needed to—how long would it be before I wouldn’t need the pills anymore.

One day, while on the medication, I had this kind of sudden emotion, instantly overcoming, it was the most extreme sadness I had ever felt. Like a hollow empty hole in my stomach. And my clinicians asked about this feeling. I said I don’t know how else to describe it but it feels like something the devil would want you to feel. I'm not religious in any way. I have no thoughts on heaven or hell but that was the only way I could think to vocalize it.

When I went to my new psychiatrist about a month after the event, I told her what medications I was currently taking and she told me that I was taking enough medication to sedate a small horse. I told her that I felt exhausted, detached from myself and others, as well as mentally foggy. People were asking me if I was high, and for reference, I don’t do recreational drugs of any kind.

About a year later, I was taking different types and doses of psychiatric medication but instead of experiencing the fatigue and fogginess, I became—I was really flat, not reactive and at times, very apathetic. I would describe myself as being unable to express emotion. In addition, my friends would say that I was delayed in my reactions and I was not really there, I was somewhere else.

Even though I was seeking multiple forms of mental health treatment, this was what I was experiencing and I felt that I had to continue living with my life as it was. The time came when I had to interview for an internship and I found a particular placement that was exactly what I had envisioned for my career. I spent a month preparing for the interview and I was not really nervous about answering questions about my qualifications. I was actually more nervous that I would not be able to express how badly I wanted to be there.

● ● ● ● I tried everything to be able to show the excitement and trust and caring that I felt inside. During this time, I felt like I was not really anything and I was so afraid that I was going to have to live like this my entire life. So, in a major effort to get better, I stopped taking all the medications, and after about a month or so, I saw my outgoing personality come back and I was once again able to sort of communicate well and think clearly in taking information.

In addition, I was able to rekindle as well as form new relationships and friendships. For my wellness plan now, I'm actively seeking and developing positive and supportive social connections as well as through DBSA. I am focusing on improving my self-confidence and my ability to trust others as well as developing the skills necessary for my career.

Through additional treatment, I would like to achieve the ability to self-soothe as well as foster self-compassion and utilize coping skills. I would like to see more strength-based and person-centered approaches to psychiatric treatment as a whole. And to, sort of, wrap it up, guys, I still experience symptoms of depression although much less frequently as I used to. I'm open to taking medication in the future but unfortunately right now, the risk really outweigh the benefits for me. Thank you.

Facilitator: Thank you so much, Allie. Our next speaker is Christy Nur (ph).

Christy Nur: Thank you. When I was asked, "When did your first episode of depression occur?" I was puzzled. It's easier for me to describe episodes of contentment. For as long as I can remember, all I've wanted is to be happy. I was not sure what that was but I didn’t think I had it. The first time the word depression was applied to me, I was much older. Shortly after my 40th birthday, I gave birth to twins. That was a joyful but also a very confusing time.

I was sharing some concerns with a colleague and he said, "You have post- partum depression and you need to get help." I was sure he was wrong. That couldn’t be true because I would have sought help, had that been the case. I was just a little bit nervous about my babies. That was not however the first time I looked for answers.

I spent four years in group therapy and received a sociology degree. I didn’t know I was depressed but I loved school. I have been to therapist to try and fix me. I wanted to change my thinking because I just couldn’t accept the bad things or the good things that happened to me. Each time I wanted help, the search would start over. Find someone with an open schedule, accepting the right insurance, close to my work, and then, "Could I really talk to them?" I could not find a permanent fit.

● ● ● ● Through therapy, I was able to recognize that most of my fears were unrealistic and I began to be able to endure my family, my job and my life. I did not feel completely whole or better, or happy or content. And my therapist wondered if I might consider medication. I would not. I did not want to trade feeling bad for feeling nothing. But I was desperate. I needed something better in my life. In the 90s, everyone was taking Prozac, and so did I for a while.

I felt no change in my attitude or my response to events but fortunately, I also did not feel suicidal, which was one of the things I was told to look out for. A year passed and then two, while I tried Paxil, Zoloft, Bupropion, and thank goodness, that was before direct to consumer marketing or I'd have tried many, many more.

Each had to be taken for a few weeks while I assessed my progress. Different times of day, time of release, two medications together. Each has slow and frustrating process. I settled on Bupropion, not because it was a wonder drug but because I didn’t think I felt quite as bad while I was taking it.

A few years later, with some more experimentation, I added Lexapro. I continue on these two medications and have had a relatively stable emotional life for the most of the past 15 years. A few years ago, I decided to wean myself off one of the meds because I wanted to reduce the unpleasant side effects. Serious sweating and a decrease interest in sex. After a few weeks, I was a raging bitch and I was irritable with even nice people.

I decided that two med cocktail was still my best bet but I think it could still be better. I still become profoundly sad for no apparent reason, sometimes with very good reason. It may sound like I have spent my life in a crumpled heap, whining and wailing, and that is not so. I've had a successful career in hospital administration but I think I could have been so much more powerful and effective had I not had these episodes of my life.

If I didn’t spend so much time worrying about being a fraud, being less than enough, real confidence instead of a facade, like putting on my armour to go to work, I might have allowed me to push my good ideas instead of giving in to those older and more masculine than me. I called my most recent therapist who had retired a few years ago. I had agreed to do this panel but I began to think I wouldn’t be any good at it. I began to worry that I would not really help the cause. She told me I would.

And then she said she had always called me "designment" because she didn’t want to label me in a way, according to her, I was massively, majorly, depressed.

● ● ● ● And she was concerned that should I change insurance companies again, I might lose my coverage. That's so wrong.

Modern medicine has progressed so much in 40 years in terms of target in medication. Yet the treatment for depression is still trial and error, as far as in sporadic on this medication but it won't work immediately and maybe not at all once your side effect the same as you've had or worse, including thoughts of suicide. Again, that's just not right.

Can we not move from trial and error to targeted therapy based upon some reasonable criteria, criteria that I can understand and help to identify and assess? If these medications are designed to bring about brain balance to fix the chemicals in my brain, can we not measure those chemicals to decide which medication might work fast?

How do we know whether a serotonin reuptake inhibitor might do the job? And how much serotonin should be re-uptaken to work best? Without a framework for wellness, self-reported experiences of a person, struggling to trust their own feelings are not the best way to determine medication of that fitness. We have to do better. Thank you.

Facilitator: Thank you so much, Christy. And thanks to all of our panelists. One of the things that I was struck by is the courage that it takes for you all to come up here and share these incredibly personal stories and feelings with us. And I think you provided us with a wide variety of experiences and prospective about the impact living with depression has on your everyday life. And then the discussion that follows, I think that we're going to build on some of what you told us today. So, let's give them all another round of applause.

Male Speaker 1: I'm a disabled veteran. And my experience with depression started before I went in the military. At the age of 16, I signed up for Vietnam, and I wanted to commit suicide.

And then, when I went in the military, later on, I had a challenging job. And what it did was it had me in structure, to where I never addressed the depression.

Years later, when I came out of the military, after 13 years, I received a diagnosis that I didn't want to accept because I was living in a culture where we don't speak on being—having those stigmas that he was talking about. We don't speak on being depressed, and we don't speak on having a psychological problem.

● ● ● ● And it was a cliché of "man up." And I had to live with that experience for a long time, and I found myself going past my mother's house and finding out there's— she had a stack of mail, and it was all from the IRS, all the different jobs I've kept going to and walking off of and wondering why I did it.

So what—my experience was to say I couldn't afford medication, so I self- medicated. And later on, I became very compulsive and insidious with my behaviors—that my mind would always say, "End this now."

So the most important thing about going and getting help, for me, was that I became educated on some of the things that was going on. Whereas, though, prior to that, I wasn't educated, and I didn't know much about this Greek language of diagnosis that you all have. And now that I know, I'm learning to pronounce some of them.

And basically, what I'm saying is that, I didn't receive society in my life until I turned 50. And I ended up getting a wife at that period of time. And I'm still experiencing that family, spouse, and romantic relationship thing today.

I don't sleep in the same room with her, most of the time. And our conversations are short. And the relationship is beautiful, but how do you handle someone that don't want to receive success? And isolation, feeble positions, all of these things that goes on? And you have a family over here now.

And then they offer me medications, like, you were talking about earlier. The medications, sometimes they work, and then, other times, they don't work. It's like a rollercoaster.

And now I'm in the rejection stage of my life. Not only do I reject medicine, I reject society.

Facilitator: I hear you. So thank you very much for sharing that. I think that that hasn't really much been mentioned—the stigma of depression and the effects that has on your willingness to seek help and treatment and become, you know, more educated yourself about your condition. It sort of is very isolating.

Are there any other comments in the room? Okay. Here's one over there and then one more, and then I think we have to move on.

Kara Ultimus: Thank you. I'm [Kara Ultimus 04:00]. When I think about impact on life, I think about being raised by two parents that suffered from depression and being a child. And I can look back, now, and know moments that I saw as highly unpredictable and scary, as moments of depression that they were

● ● ● ● experiencing, where they would go from normal to removed, to angry, and managing that as a little person.

And then—and how that's changed me and my expectation about the world and people around me. And the ability to connect them, especially as a child—my father, in particular, I didn't connect with till I was an adult with diagnosed depression. And one of our major moments was talking about what that was like and how to manage medication, which is kind of bizarre.

But then, as a parent, now, I think about—how do I manage myself to not carry that another generation forward? How do I make myself more predictable so that my daughter isn't trying to manage or understand me, so that she won't be in her twenties or thirties thinking back to those moments to understand what childhood was and why.

And then, earlier, you asked this question about how those moments of depression affect other points in life. And I can speak personally and say that most of the time, I'm fine. And I have some very brief dark periods of intense depression.

And those periods feed into my psyche on all the other days, for what can I take on and what can I do and what jobs am I best for, even though those are great days and even though those moments are few and far between. And so I do think that that matters.

Facilitator: Thank you very much.

Catherine Wickman: Thank you. [Catherine Wickman 06:08]. I wanted to address some of the financial circumstances. My very first depression, when I was 14, and I didn't know what it was, and I ended up immediately quitting my job. So even from the beginning, it affected me.

I haven't been able to work full-time since 2007. When I was working, I wasn't able to make it through a month without having to take sick leave. So I was perceived as being very unreliable.

I was not able to interact with my supervisors in a—you know, I was imagining things and, like, all of those kind of things. So I was not able to interact with the supervisors in a way that I could advance.

Even once the medications, once I finally found a medication that worked and, all of a sudden, my depression was diminished, I realized—it was like, "Oh my

● ● ● ● God. This is what other people—this is how other people are interacting. This is the kind of relationships that they're having."

But then I realized that I had so many bad habits due to the way I was interacting under depression. So that made it very hard, even when things had cleared up to some degree.

I was constantly maxing out my—I can't remember what they're called but the annual health leave things. Because I haven't been—and spent a fortune on treatments. Because I haven't—because I've been underemployed for so many years, I haven't had money going into a 401K. I haven't been able to do any long-term planning.

So, you know, financially, in the past and the present, I'm not making as much money. And in the future, this is going to affect how I'm going to be able to take care of myself.

And for the sake of everybody, I'll drop—I'll let it go.

Facilitator: Thank you. I think those are very helpful and important points to make. And again, what I sense and see here—there's a lot of interactions between things, you know, patterns that build up, how it affects how you're perceived on your job which, in turn, affects your financial situation. And it's a—it keeps going around, and the idea is, I think, how to—how do you break out of that cycle?

So thanks to everybody who participated. Now I'd like to turn to another topic. And I'm going to explore some of the responses from the Supporting Wellness Survey.

As [Waco Pollack 08:50] shared earlier, DBSA had a tremendous response to the Supporting Wellness Survey, which, I want to make sure you know, continues until December 31. So if you haven't participated, please do. Over 6,000 peers have responded so far.

So we want to use our time, some of our time today, to explore, in more detail, some of the responses to the survey.

As you can see from the slide, 43 percent of respondents shared that their overall health had worsened since first experiencing symptoms of depression.

There are many reasons why people could be experiencing an overall decline in health, and time today won't permit us to explore all of them. But we would like to explore the impact living with depression and another health condition might have in contributing to the response that the overall health has declined. And I

● ● ● ● think Dr. [Sacks 09:46] shared some statistics on this, as well, about the effect of depression on your overall quality of life.

So take a look at this. These are sort of the—some of the issues that come up when you start talking about what the demands of depression on your whole health are.

We're going to work this the same way we did the previous discussion. DBSA staff have the microphones. If you want to comment, raise your hand. If you're participating via the webcast, type your comment into the comment section, and we'll be able to read some of them aloud.

Again, try and be brief so that we can hear from as many people as possible. Keep your remarks, if you can, to one minute or less. And let's try and sort of stay on this topic, if we can. We'll be handling other topics, you know, later in the session. And so if you have something that deals with something else, we can come to that later.

And just to—I think, just to kick this off, I'm going to build on what one of our panelists said. Shelby shared that it's difficult for her to manage the symptoms of both polycystic ovarian syndrome and depression at the same time.

So when you're thinking about the demands of managing your whole health, how do you balance the strategies of treating one condition versus another? Has anybody—can anybody address how you do this juggling? Go ahead.

Female Speaker 1: Thank you. 11 years ago, I was diagnosed with a neurological disorder called dystonia. And it's the basal ganglia portion of my brain misfiring and causing my face and neck and eyes to spasm.

When that diagnosis came through, the only thing I could think about was— "How am I going to kill myself without killing myself to my family?" I didn't want them to know I was going to take my own life.

I researched, went through everything. This was all happening at the same time as divorcing my husband. So I just had one more thing that I needed to deal with.

Over time, with a lot of prayer and a lot of strength that, I really don't even know where it came from—but it came—I was able to get to a good place with my dystonia.

And then I found a fantastic group of people at Pocono Hospital, DBSA Pocono Mountain. And they have helped me so much with the depression side of it.

● ● ● ● They've guided me. And that was something that I needed so much because you can only take so much on your plate before you just say, "Okay. I'm out of here. This isn't going to happen. This isn't going to work."

So dealing with both of these conditions, the neurological piece of it and then the depression side of it, right now, what I do when I feel myself going down, I give myself two days. "You've got two days to crawl out of this hole." And honestly, it doesn't usually take me two days anymore. It may just be an afternoon.

But I sit on the couch, and I have my little pity party. And then I pick myself up and brush myself off and move on. Thank you.

Facilitator: Thank you very much.

Female Speaker 2: Hi. I'm going to just give you a little different perspective. Both my kids were diagnosed with Long QT syndrome, probably about ten years ago. And the thing the cardiologist said to us is "Hope they don't get depressed." Because all the antidepressants elongate the QT interval.

So fast forward, this past August, my son tried to kill himself. We can't get a medication that he can take because of the Long QT, so he's on something that elongates the QT.

So we're risking that part, you know, hoping—you know, he had a sympathectomy done, which reduces the adrenaline in his heart. But there's got to be medication out there that will work with that diagnosis.

Facilitator: I think that's a really good example of the tradeoff that you have to make and how difficult these are with the limitations on the medications and the side effects of the medications that you—that exist today, for both conditions. And hopefully, they'll learn more about what causes, for example, prolongation of the QT interval.

Female Speaker 3: As a caregiver, I'll just speak on behalf of my daughter, who happens to live with major depression and polycystic ovarian syndrome. And she called me one night and said, after visiting with her psychiatrist, trying to find a remedy for both— and she said, in tears, "I guess I'm going to have to decide between my physical pain or my mental pain."

And she said, "I can't live with the mental pain, so I guess I'll just have to learn to live with the physical pain." And that's the tradeoff many of us have to make.

● ● ● ● Female Speaker 4: So I can definitely identify with Molly and Shelby. I also live with PCOS. And especially—so this would've been late '90s, early 2000s. PCOS was all about a lifestyle disease. So "Just eat better."

And it was done in such a stigmatizing way. But eating has been, you know, a coping mechanism. I'm always working on self-soothing tools. But sometimes it's between, you know, cake and suicide.

So, you know, which, again, it's the "Which one are you going to live with?" Is it going to be the hormonal imbalance because I can't take care of myself physically? Or am I going to comply with my therapist and do these other things to take care of my mental health? So I can identify with that.

Sasha Audie: Hi. [Sasha Audie 16:45]. I'm executive director of PCOS Challenge. Don't mean to have this be a PCOS party, but it's quite relevant to the—you know, just the discussion that we're having, is—my personal story—when I was diagnosed with PCOS, my gynecologist told me to come back to see her and to go to an endocrinologist.

The endocrinologist told me to lose weight and come back to see him in six months. So I tried to go see a nutritionist, but I was told insurance won't cover that because I wasn't diabetic, one of the very things I was trying to prevent.

So many of us, as patients, feel like we have to take so much on to control, not only our conditions that we're diagnosed with but the comorbidities, and manage medications, manage relationships, manage everything. Yet we're left alone. We're left—we felt let down.

And there needs to be a huge overhaul in how we view the body, the female body specifically, as well, and our experience with our health and wellness, and understand that, okay, PCOS may not be just a reproductive disorder. It affects whole health, and it affects quality of life.

Many of us have trouble maintaining relationships, maintaining jobs and, you know, in academics, because of dealing with depression and other things that are not—we don't have access to the proper management and a proper healthcare team. So thank you.

Facilitator: Does anyone have any comments on the strategies that they use to manage both depression and another health condition if they can't afford to treat both? If it's a financial issue, how do they make that decision?

● ● ● ● And another question I'd like to address is, how do you get your clinicians to work together? There's been a lot of discussion about how your clinicians don't talk to each other. And they don't—you know, each one is treating their own aspect of you but not the whole you. So either of those questions.

Male Speaker 1: Well, the application—that's what I call it—the application itself, I had to—I had to do what they call an inner toolbox and put some tools in it. And the first tool that I started using was a hammer. That means every time you said something to me, I would hammer your comment. I would just hammer it.

And I learned there were other tools available to put in my toolbox. So what I did was I went and I found out, through education and application, that, you know, I can receive some of these tools for myself. It took a desire and a willingness to do this.

And now I have a toolbox with, you know, tools in there, today. And what I do is I humble myself more than I'd ever done before. And I think about the tools that are needed for the specific job instead of just grabbing anything out the box.

And what that do for me today is that it keeps me on track to continue to practice these things and say to myself that this is what I have to do in order for me to be able to be sociable with society.

Facilitator: Thank you. And one more, I think.

Female Speaker 5: You asked about strategies. For me it was called California—California Closets. When I moved into my new home, I realized that I could put my car in the garage and realized that wasn't a great idea.

So I got California Closets. And I cannot get my car in my garage. And my friends laugh, and people around me laugh. But those who know about my brain disease don't laugh. And they go, "We're really glad you can't get in your garage."

Facilitator: Thank you. Okay. I think we have to—we have to move on. And hopefully, some of what you might want to say will come up in one of the other sessions.

So now I'd like to change course and talk about a different impact of living with depression might have on your life. In the Supporting Wellness Survey, 86 percent selected, as a high priority, when asked about aspects of wellness, "Ability to be independent or act according to my own will."

● ● ● ● So we want to understand a little bit about what that means to you. So we're going to go back and use a polling question. I'm not going to go over the details of this. I think you all got it really well, on how to do this.

So the question is, "When reflecting on ability to be independent or act according to my own will, which best defines this aspect for you?

A. Ability to do work I have done previously or have received training or advanced education to do. B. Ability to engage in social activities that I've enjoyed in the past. C. Ability to explore new employment, training, or academic opportunities. D. Ability to explore new leisure time activities or social situations. E. All of the above. F. I don't know."

Hopefully, you'll pick just—each of you pick one. I'm going to just wait for a minute or so until the bars stop moving.

Okay. Well, this will be difficult to deal with. "All of the above". "All of the above." Well, you know what I'm going to do? I'm going to start with "other," with the one that isn't listed. So if anybody who chose "other" would like to help us to understand what item is missing from the list. Is it somebody in the— anybody in the room who'd like to address that?

If not, I'll—I'm going to go to A. and C., "Ability to do work that you've done previously or have received training to do" and then, related to that is—that's looking back and, you know, doing what you used to be able to do. And the next is doing something new—"a new employment, training, or academic opportunity." Would somebody like to speak and pick one or the other of those?

Kim: Hi, my name is Kim. I'm a registered nurse. When I had my breakdown, my colleagues blackballed me. I don't practice as a nurse anymore because of the stigma.

So now I'm a peer specialist. I work through the VA. Thank you. And thank God I found the VA, or I would be homeless still.

Facilitator: Thank you for sharing that. Over here.

Eric: My name's Eric. For me, I was in a situation with both depression—it's been now considered to be resistant depression. And I have another comorbid health condition that contributes clearly to the depression.

● ● ● ● I went through a period of unemployment, [inaudible 25:40] unemployment and eventually had to make the decision to go on disability, which was a very difficult decision to make, I mean, because it felt like failure. It felt like admitting to failure.

What I found, though, was I made a decision that, well, I'll apply for disability because, you know, well, maybe in the—maybe I won't get it. I mean, it's hard to get. Or maybe, by the time the disability is approved, my depression will somehow miraculously go away or I'll win the Powerball or something, and then life would change.

I was fortunate to get disability. I also, as I was going through that process, began to get involved with a number of volunteer organizations here in the DC area, which gave me a sense of purpose and sense of meaning.

So it was a combination of the financial resources of the disability—I'm fortunate I got a fairly good disability payment—and being able to structure my life, financially, that I can live. I'm on about 40 percent of what I used to live on.

So I don't live in the retirement—you know, I'm retired now. And people say, "Oh, that's great. You're retired. You can go off and do stuff." Well, no, I really can't.

But my symptoms are now sort of managed. I'm still depressed. I have actually been in a depressive state for the last couple of months for a variety of reasons. And I'm aware of that, and we're working with my psychiatrist.

I want to go back to, actually, a previous question, when you asked about—how do you coordinate things? I actually am in an integrated healthcare practice, and I have found that to be very helpful because my psychiatrist and mental health people are in the same building as my primary doctors. And so that has been very helpful.

But basically, for me, the—it's the combination of getting some meaningful volunteer work and meaningful—and then the financial stability.

Facilitator: Thank you very much. Okay. So I think I might've moved too hastily by not addressing the 56 percent that said, "All of the above," because that means that some of this 56 percent, whether, you know, have the problems of engaging in social activities that they've been enjoying in the past and also are concerned about the ability to explore new leisure time activities or social situations.

● ● ● ● Would somebody in the 56 percent like to address those two things, which we haven't really talked about? Anybody? No?

And would anybody who said "other" like to say something? I really would be very interested, I think, in hearing any responses to this from other not listed here or any aspects of this that are not listed. Nobody on the web? Nope.

Hey, guys, come on. Here's somebody.

Male Speaker 2: Hi. The reason I would choose—the reason I chose "All of the above" is that my experience with depression shut me off from everything. So I no longer had the job that I had before my major depressive episode.

I isolated myself. When I—when you don't have a job, you don't have structure in your day. You don't have energy. You don't pursue leisure activities.

When I was first, luckily, laid off and not just fired, people said, "That's great. You've got all the free time you need." It's like, "Yeah, but I'm not bringing any money to write the checks for the things I'd like to do with the free time I now have."

And it's made it very difficult to get back into the workforce at a level at which I believe I could be capable. And some of that is confidence, and some of that is cognitive loss, you know. You don't think as well when you're depressed.

And so it really just really impacts my entire life in ways that—yeah—lead me to the "All of the above" category.

Facilitator: Thank you. I think that's very helpful. There's a—Lisa.

Lisa: I think I read the question differently than most people. I did answer in the 56 percent, but I want to speak to the 11 percent, if I'm reading it incorrectly.

And I want to speak to this gentleman's comment about finding the spark or the will or just, I guess, what—if I'm answering to the 11 percent, I think I would include in this category of your own self-talk and finding, you know, as a source of maybe where the depression and anxiety comes from.

So I guess I would include that in this question, as well, if I'm going to speak to the 11 percent.

Facilitator: Great. Thank you. There's one over here.

● ● ● ● Female Speaker 6: I'm going for a long shot here. For instance, when somebody has been in a job and they've been injured on that job and they go out on worker's compensation, they're afraid of how they're perceived by the public. "Oh, look at him. He's out on worker's compensation, yet he's out walking a block."

With this—wait a minute, here's this person that is—they don't have the ability to work because they're so depressed and they're so this and they're so that. Yet they're out taking a walk in the woods. How can they do that if they're so depressed that they don't want to leave their house? But they're leaving their house. All of these things.

It's like our perception of how we feel we're being perceived by others. Like, are we supposed to stay in the dark? You know, is that part of it? Are we afraid—if we are doing something proactive, are we going to be looked at as, like, "There's nothing wrong with you. If you can do that, you can do this job. You can take these classes. You can do all of these things"?

Because people don't understand that you don't stay in the dark 24 hours a day. You do have good times. You do have times when you can function and you can do these things. That's all.

Facilitator: Thank you. So it relates to the stigma, I think, the stigma aspect that people have raised a couple of times now. You have another comment. Okay.

Male Speaker 3: Yeah. I just think it all goes together, right—the social aspect, the work aspect. You know, when I've gone through difficult periods of depression and I haven't felt like I've been able to socialize, then that lack of confidence bleeds over into my workday, my ability to perform in my work.

And in the same token, when I feel like I don't have the confidence to be able to perform at my job, then I have no interest in going out and socializing because I feel I have nothing to offer when I'm in conversations with people. So they both play into each other in my experience.

Facilitator: So they relate to each other, and one affects the other.

Can I just explore a little bit—what does it mean to you to be independent or act according to your own will? Does anybody want to sort of address what that actually means to them?

What would you—you know, because part of what we're going to talk about in the next session is going to be treatment outcomes and what would you like in terms of—what would you like to see? So before we sort of break, which is—we

● ● ● ● have in about a minute or two to break, before we break, what—if ability to be independent or act according to your own will is important, what does that mean to you? What does that look like to you?

Female Speaker 7: Hi. So I've been told by providers, quite a few times, that I shouldn't work and I should not seek out peer support for not being able to trust someone else with mental health issues, both of which I felt were really counterproductive and dangerous.

And I think that kind of goes with the traditional model of mental health treatment, where you're supposed to kind of appear stable and in sort of a stable place before you can work or even start experimenting with work or looking for work.

And so I spent months not working, and I really wasn't sure why I wasn't working. And that's been very harmful.

Facilitator: One more. This'll be, I think, our last comment, and then we're going to break.

Anna: Hi, my name is Anna. I think I wanted to speak to your question about what will and determination is about and how that gets intertwined with attempting to partner with care providers who are—can be put in places where they're given a lot of—I think we, as a society, we give medical care providers a lot of power in giving us a diagnosis.

And so part of the legacy of cultivating health is to step away and understand what resonates and what doesn't resonate. And for me, what's been tremendously exciting in this field is a shift in some of the language—that we're consumers of medical services. And I think it gives us a lot more power in situations where we're dealing with people who are there to help us problem- solve. And it's not such a hierarchical dynamic.

Facilitator: Thank you very much. Okay. I think it's time for our break. We're going to take a short break, and we'll start back promptly at 2:45. Okay? Thanks so much.

Facilitator: Okay. So on question number one, “What is your age?” so you can see the breakdown of people who are both in the room and on the webcast. Gender more female than male. Which of the following applies? So it feels like we have a diverse group in terms of people who are both living with depression or are peer supports. And here is the breakdown of how long has it been since you first experienced symptoms of depression. And it looks like many people in the

● ● ● ● room, the majority of people either in the room or on the webcast, have been dealing with this for quite a long time. So I hope that’s helpful.

Get to where we’re starting. Okay. So this is our second session of the afternoon, and we’ll be trying to better understand the unmet needs and what constitutes treatment effectiveness for people living with depression. We are fortunate to have four panelists this afternoon that will share with the audience how they’re managing living with depression and what they hope for in treatment. So our first speaker is Yvette Murray.

Yvette Murray: Good afternoon. Some of you missed the California closet thing, so I’m going to clarify. If you take your car into a garage, and you put the garage down, you will carbon monoxide yourself if no one comes to get you. Can’t do that in my garage with California closets.

So my name is Yvette Murray. I’m a clinician, I am a woman, I am a woman of color, and I have a gun pointed at my head daily. I am in a progressive, lifelong battle with depression. The FDA must require pharmaceutical manufacturers to view people like me as people and not profit margins. It is not enough to minimize symptoms. Every day I wake up with fear that my disease will derail my ability to earn a living, be a parent, productive citizen, not a drain on the health care system, and be a positive impact on our nation’s GDP.

The first manifestation of my disease occurred with my first suicide attempt at the age of 13. Over the course of the next 30 years, I have experienced severe depression, leaving me chained to my bed for weeks at a time. Years of misdiagnosis and ill-suited pharmaceutical treatments have resulted in medication-induced episodes of mania, suicidal ideation, emergency room visits, long and short-term partial care hospitalization.

I live with debilitating anxiety, agitation, inappropriate outbursts and behaviors, migraines, lipodystrophy, hair loss, inability to concentrate, no libido, body aches, and active thoughts of self-harm. I currently suffer from obesity, which in turn has resulted in social isolation, diabetes, elevated blood pressure, high cholesterol. I face other possible and preventable diseases—like heart disease, stroke, COPD, early-onset dementia—as a consequence of my disease and the medication. Permanent disability is likely to be in my future. I live with the knowledge that my life expectancy on average is 10 years shorter than people without my disease. That’s a decade lost to my parents, siblings, children, grandchildren, friends, and as a tax-generating, productive asset to American society and our economy.

● ● ● ● I can trace my disease back four generations. Had genetic markers been part of pharmaceutical research and development, I would not have spent my adolescence and majority of my adulthood improperly medicated. Genomic testing would have helped my providers diagnose and optimize treating protocols. No one should spend decades in psychic and physical pain when we have the technology to identify treatments that are more likely to be efficacious, resulting in the amelioration of side effects and long-term risk.

I beseech the FDA to require that as part of research and development pharmaceutical companies are required to conduct female longitudinal clinical studies to account for the complex interplay of estrogen and testosterone over the course of a woman’s life. What I needed as a prepubescent teen was very different than what I needed as a menstruating, pregnant, menopausal, and soon to be, I hope, post-menopausal woman. During all of these phases of my life, my medication regime has needed to be adjusted. I anticipate this will be the case for the rest of my life.

It is imperative that drug toxicity resulting from psychotropic drug interaction with other pharmaceuticals be evaluated to minimize the harmful side effects of psychotropic medication on the body and mind. Longitudinal studies will result in evidence-based diagnosis, protocols for treatment to safeguard women’s health and wellbeing.

If it had not have been for my support system, I would’ve never finished my education. My anxiety and depression negatively impacted my ability to process information, focus, complete papers, take exams, and meet deadlines. I was hostage to my bed and with suicidal ideation. Due to the severity of my symptoms and thoughts of suicide, I was forced to withdraw from college in my junior year.

I have been unable to maintain full employment. My symptoms only allow me to take positions that will not contribute to flare-ups or manifestations of my disease. I have been fired from short-term positions due to my uncontrolled and erratic and inappropriate behavior and excessive sick days.

Crushing anxiety and depression have resulted in important missed celebrations, significant loss of work productivity, hospitalizations as well as other activities that make life meaningful. Due to my erratic and bizarre behavior, my support systems have been shattered. I have lost friendships, been shun by family members, and seen the end of my marriage.

No one should have to live or die in pain due to lack of ability to pay for their medication or hospitalized as a result of medication-induced psychosis. I

● ● ● ● currently do not have health insurance because I am unable to afford it. The cost of my medications and professional treatment are more than my monthly mortgage payments. At times, I go without proper treatment and/or medication to keep the lights on or stay warm.

I am only one of over 11 million people living in the United States with this debilitating disease. Unfortunately, we lose about 1 million people a year who successfully take their lives due to misdiagnosis and ineffective treatment. I don’t want to die when we have the knowledge to do better. Thank you for providing me with the opportunity to share my experience with this life- threatening disease. Thank you.

Facilitator: Thank you, Yvette. Our next speaker is Patrick O’Brian.

Patrick O’Brian: You’ve heard a lot today from people who live with depression. It’s important to understand that they do not stand alone. I’m here to share with you the journey of those of us who love and support our children, spouses, siblings, parents, and friends who are struggling with this disorder.

My story begins like so many caregivers in the emergency room. We rushed my daughter Katie to the psych hospital after three days of growing anxiety and sleeplessness. It was heartbreaking to see her so terrified and helpless as hospital staff searched her, removed her belt, took the strings to her hoodie and her shoelaces along with her backpack and purse, and hours later, escorted her to the psych unit.

The admitting diagnosis was severe depression with a psychotic break, which we interpreted as a nervous breakdown. And, you know, we knew it was serious, but we just assumed that after rest and a shift in her graduate school deadlines, she would recover. We had no idea. We had very little help in setting up a post- hospitalization treatment program and absolutely no experience with therapists or psychiatrists. We knew virtually nothing about the diagnosis, so feeling lost and overwhelmed, we began our journey.

There’s so much to learn about depression itself and the medications to treat it. The terms can be confusing and the drug names unpronounceable. We had to parse out the differences between psychiatrists and talk therapists. We stumbled from one practitioner to another, each having a different set of ideas and prescriptions. Getting a diagnosis is a relief at first. Then you learn there is no cure, and treatment is lifelong.

Slowly I realized that Katie’s wellness depended on how well we all could learn to manage a chronic illness. Mood disorders put a severe strain on the best of

● ● ● ● families. Katie’s lucky to have two parents who adore her and a stepmom who treats her with the same love and care she gives her own two children. But in any family system, the illness takes over. The desire to fix the problem fast creates an environment of scrutiny and over-functioning.

In the beginning, we grilled Katie with questions. Had she taken her meds? Did she get enough sleep last night? Was she making good choices? As a 23-year-old who’d been living on her own for five years, she resisted, and rightly so. We realized we needed to treat her with respect while providing the right amount of guidance in the right way. This took years.

We also had to figure out how to manage our own stress. Excuse me. When Katie was depressed, we felt anxious and helpless. We’d see her sleep all day or unable to shower or even get up to eat and failed to understand the will and courage these simple acts take when she was so sick. When she was mood stable, we still live with a low-grade fever of concern, always waiting for the other shoe to drop. It was if the illness had become a third-party in our relationship. She and we had to discover what the limits were and where the triggers might lie.

And then there was the odyssey of the medication. We had to find the right combination of drugs with a schedule Katie could reasonably follow and side effects she could tolerate. This process was slow and painful. The lag time between getting a new prescription and seeing the effects was frustrating, usually a few weeks before we knew whether it was helping or hurting. She didn’t always take her meds either, since the side effects could be so dreadful. She suffered weight gain, hair loss, essential tremors, brain fog, forgetfulness, and sleepiness. At 23, it felt very unfair and so untrue.

My wife and I wobbled our way through the vicissitudes of the disorder for two years before we found the DBSA friends and family support group. That was a gamechanger. It helped us to learn to choose our words more carefully and sensitively. We gained perspectives on Katie’s diagnosis and a deeper understanding of our role as caregivers. And we could lay down our frustrations, sadness, and anger in a place where we were safe and understood. Excuse me.

One of the most important insights was that the behaviors that annoyed or scared us were symptoms of the disorder, not behaviors that Katie could control. This activated our empathy, helping us to avoid criticism or impatience. Katie’s journey took a definitive turn when she checked into an intensive outpatient program. She learned the skills she needed for self-care. With consistent med management by her doc, she was able to dial in the proper

● ● ● ● medications and dosages. And she was able to set clear goals she could follow. Family therapy made us active parents, participants in her wellness.

Just a few days ago, Katie turned 30. She lives in wellness now thanks to a very skilled psychiatrist, a compassionate therapist, support from family and friends, an effective drug cocktail at a low dosage with minimal side effects, and an active investment in her own health. She limits her partying, values her sleep, keeps up with friends and family, and sees her therapist weekly. Her sense of humor has totally recovered, and she is a valued and trusted employee. She shows up on time and sticks to her commitments. She even brings the car back when she said she would with gas in it. Her mood fluctuations are mild and make sense in the context of her life. Job hunting is stressful, for example. But her level of anxiety is not over the top, and my low-grade fever has gone away.

But—always a but—there’s a clear recognition of the prize she’s paid. Katie feels she’s lost a big chunk of her life to this disorder. She’s gained knowledge and wisdom and a certain self-awareness, yet at 30 she feels as though she’s just no farther along than a recent college grad—working a low-paying job outside her chosen field, living with roommates in a Bohemian apartment, future cloudy, and finances tight.

Could life be better for her? Absolutely. Her disorder limits her options. She can’t go travel the world, move, or change jobs without worrying about the consequences. She needs excellent health benefits with zero gaps in coverage. Her relationship with friends and potential mates is colored by her illness and the question of how much and to whom to disclose her condition. She worries whether she will be able to have a family, not wanting any child to suffer the pain and setbacks she’s faced.

When I told Katie that I’d be testifying today, she said, “Remember, Dad, I’m your daughter, not just a pile of symptoms. There’s so much more to me than that,” which is precisely the point I want to leave you with today. Symptom relief is not the only goal, and we all have heard that over and over. We are looking for treatments that empower people to live their best lives. No one with a serious mental health disorder should be forced to accept a second-tier life. My daughter and millions of others just like her—excuse me—deserve the opportunity to use their unique strengths to pursue lives that have meaning and impact. Imagine the benefits for all of us if the therapy we offered could make that a reality. Thank you.

Facilitator: Thank you, Patrick. Our next speaker is Sinuet.

● ● ● ● Sinuet: Hello, everyone. First, I’d like to say a very big, heartfelt thank you to DBSA and to the Veterans Health Care System for all they have done and continue to do for me.

My name is Sinuet, and I am here to share with you my story of living with depression. In 1990—so 28 years ago—as an active duty army soldier, I was diagnosed with depression after trying hard to understand the reasons for my concentration loss, restlessness, and loss of enjoyment in being with and around my children and my wife. In being diagnosed, I was also told that I had sleep apnea.

While my depression has changed over time as I have changed, with both high and low points, the many treatments—and I do many treatments—that I have been assigned over that time period have only allowed for direct focus to be placed on the depression and not other underlying conditions.

What was not taken into consideration were, like I stated, the other many health care conditions, such as the sleep apnea, which was never addressed for several years, and how it was affecting my level of health, and also socioeconomic factors, such as how was my living conditions. What were they like? Did I have any pressures from debts? Was I in a relationship—which I was—or did I have immediate family to assist me in providing a family or friendship bond?

Or what was my cultural history norms and needs? And that factor right there, that last one that I just mentioned, is a very big one for me because I believe in a lot for my cultural history. In essence, how has and does or would my cultural upbringing affect my depression treatments? For example, how can my cultural heritage be incorporated into my treatment plan, where my individual sense of self is heard in a positive form instead of a negative form?

While living with depression and sleep apnea, where medical providers were not in communication with one another meant my overall treatment and all the plans that those medical providers had planned out for me—they were not taken into full account because they were not communicating with each other in order to work over a total plan for myself. The whole plan should’ve been the whole individual wellness treatment of who I am as an individual person.

Having sleep apnea, as many of you probably know, along with depression, it does have a very significant direct effect on one’s cognition, from how you think about your daily life to your ability to think properly to how you perform and maneuver through your job, through your schooling, and also how to properly stay focused and centered on what your goals are. I have learned that getting a

● ● ● ● good night sleep, for me, allows me to wake up refreshed, relaxed, and ready to tackle a life in a positive manner rather than a negative state of mind. This has enabled me to better manage the depression I live with and to have the fortitude to stay focused on living a positive life.

In the past—and I do state in the past—I have tried to manage my depression by acupuncture, massage therapy, extreme exercising, yoga, and various medication treatment plans. I can state the massage therapy, while it was good, it was only offered once a month. I was on active duty, after all. And the acupuncture sessions—I am not one for needles, so that scared me off quickly, very quickly.

Now, the exercising, that worked really well for me because it brought me back to a point of when I was in special forces and I was on the running team and the jointness that we had together, the brotherhood that we had together, and sisterhood because we did have women in special forces working. And that just made me feel better, made me feel uplifted. And it gave me another sense of purpose on how I could bring myself back into better communicating and loving more, once again, my family for who they are and myself for who I am. Excuse me.

Some of the things that medical product development designers might consider—and I use the word might consider—is treating the whole person. Several of my other panelists have said the same thing. It’s about the whole person, not just one item that you’re focusing on, one medical condition that you’re focusing on, because many times, by focusing in one direction on one level, you miss out on the many underlying or other items that could help to benefit an individual.

And by doing that, you can help a person to better understand where they’re functioning properly at and where they’re misfunctioning because they are not being guided in the right direction for their medical treatments. Or they could better understand from getting knowledge of exactly where they’re at, what they need to do to help themselves to improve, therefore helping their families and others to improve as well.

I also would like to say that medical treatments should not, in my opinion, be designed based on a person’s age or gender in specific. The ending facts, for me, are that medical professionals and other health care providers should have a shared goal of treating the entire person, the entire person, to help them achieve success in improving their overall health quality and wellness in life.

● ● ● ● I can say for myself, which is a very good end point, I am now able to stay more focused on my family’s wellbeing and my life. And I have the ability to complete my current internship for my PhD as a doctor of public health with a specialty in epidemiology and also receiving two more master’s degrees in the process. I truly thank all of you for your time. Thank you for listening.

Facilitator: Thank you, Sinuet. Our next speaker is Keith Johnson.

Keith Johnson: Hi. Twice in my life, I found myself unable to move. In August of 1982, I hit the bottom of a lake with the top of my head, shattering three cervical vertebrae: C4, 5, and 6. Days later, I began to wiggle my fingers and toes. After six weeks, I could stand and started walking. I’ve never gained full movement in my right hand or my ankle. My right side is far weaker than my left side. I don’t think of myself as paralyzed, but I am partially.

In August of 2008, I was in my office after hours. At some point, I realized I was no longer typing. I was just sitting. I could see the buildings across the river. I could think to myself, “I can’t move.” But I was behind a glass, looking out of myself into the world. Somehow I got home. I stayed in bed for a few days. I stayed off work the next week. Though I’d been in therapy and taking medication, I hadn’t really admitted to myself that I was depressed. After that episode, I did.

Being depressed and not being able to move scared me more than lying in that hospital bed, facing the prospect of life in a wheelchair. Then I was 19 years old. I was invincible and steep in denial, but I can’t deny depression. Depression traps me behind that glass, stands between me and my family and my friends. Scares me every time I feel that way.

I have chronic back pain. It’s always cycled with my mood. Am I depressed because my back pain keeps me in bed, or does my back pain get worse when I’m depressed? I used to sit for hours, focusing on the physical pain, trying to avoid the void of depression. Warren Zevon said, “I’d rather feel bad than feel nothing at all.”

About four years ago, I went for a week without back pain for the first time in more than a decade. Surprisingly, about the same time, I landed on a combination of psych meds that put my depression at bay. Since then, I’ve gotten used to feeling okay. When my back hurts, I move. I walk. It feels better. When I’m depressed, I talk to my wife or my therapist. I feel okay.

Earlier this year, I got the idea that I wanted more than okay. I was functioning, holding a job, relating to people, but I felt better enough to think I deserved

● ● ● ● happiness. To get some of that happiness, I consciously engaged with other people. I move more, I try to sit less, and I talk to my psychiatrist.

He suggested Abilify, and it worked. I felt happier, but the muscle spasms caused by my spinal cord injury got worse. When I stood up, they kept me from straightening my leg. Took me longer to start walking, so I tried Seroquel. It made it hard to wake up. I’d get up and sit on the side of the bed wide awake, and an hour later I’d be waking up again. So I’ll try something else eventually, but right now I’ll stay with my baseline.

So how do we stop this trial and error, throw things against the wall approach to psych meds? Took me four years to find a set of medicines that got me to a baseline so that I feel okay, so that I don’t think about stepping in front of a train every time it pulls into the station, so that I can hold down a job that makes a quarter of what I made in 2008. How many tries will it take to find something better? How much am I willing to get worse while trying to find something better? Or should I settle for okay?

I believe there will be ways to find psych meds have more predictable results because I believe in science. I believe in progress. Today we can test for genetic markers to see what medicines might work, but for now it only helps us decide what to throw against the wall. Can’t really tell us what will work, but I believe it can because that’s how we humans work. Today we’ll test for genetic markers to see what might work. With more research with broader trials, we’ll be able to tell what will work.

I don’t expect the disappearance of depression. But with more research, with targeted medications, I foresee less depression—better treated, better managed depression. I’ll have depression the remainder of my life. While it may be omnipresent for me, through my efforts, yours, it will not be omnipotent. Thank you.

Facilitator: Thank you, Keith. And thanks to all of our panelists for sharing their stories. We learned that treatment outcomes are personal and individualized. And we, importantly, heard from a caregiver, the only one of our panelists that we’ve heard from. I hope other people who maybe support, peer support, in the audience will speak in this session as well. But let’s give our panelists all a big another of thank you, collectively, for speaking today. Thank you.

Facilitator: Peer supporters that are participating, if they want to elaborate on their experiences and make additional comments. I don’t know why there’s answers

● ● ● ● to this, because we haven’t asked it yet. Can we wipe the answers so that we can actually do it? We have a second; see if we can do this. Worked so well so far. Perfect. Okay.

I guess people are answering it, but I’ll read it quickly. The question is: What, if any, tools do you use as a management approach for treating depression? Select all that apply—so you can do multiple answers here. One at a time. A: peer support; B: talk therapy; C: medication therapy and/or dietary supplements; D: medical devices such as TMS, neurostimulation, electroconvulsive therapy; E: diet, sleep, physical activity, meditation, mindfulness, and other non-clinical approaches; Facilitator: personal wellness plan; G: other; and H: I don’t have a management approach to treat depression.

You put a letter and then “send,” the next letter and then “send,” the third letter and then “send.”

I don’t really understand why it sometimes says “decreased.” I get that they’re increasing.

Facilitator: That’s true, the percentage has changed. Okay. Right. As more people weigh in. I’m going to wait long enough until they’re sort of stable, but not too long.

All right. You can keep going if you want, but I want to focus in on the medication therapy. About 25 percent of you shared that you use medication as a therapy for treating depression. So we’re going to have another question, a fairly complex question. The FDA asked us to ask this question. And we’re going to ask about the medications that you might take to help treat depression.

So there are 29 different medicines approved for the treatment of depressions. Their names and their classifications can be confusing and overwhelming. Medications approved for other conditions might also be used to help depression and symptoms and conditions that commonly occur together, and we’ve included some of them here. So we’re going to give you just a couple of extra minutes to look at the list, which includes brand medication names as well as some generic names. If you don’t see the name of the medication you take, please check “other.” And you can select all that apply. And again, you type in A, B, C, whatever.

I’m not going to read all the names. For one thing, I probably can’t pronounce them all. But the question is: If you take medication to help treat depression, which of the following do you currently take? A: I don’t take medication. B: SSRIs—and you can see the names of them listed there. C: SNRIs. D: Atypicals. E: Tricyclics. Facilitator: MAOIs. G: Other. H: I don’t know.

● ● ● ● Okay. Thank you for your responses to this. You can see how the responses fell out. We are going to set this aside, but it will be useful, I think, to the FDA to see what generally you’re taking. We’re going to take a deeper look at the complete list of management approaches other than medication in a few minutes, but for now, we’re going to move on.

In the Supporting Wellness Survey, in response to a question about the number of discrete periods of time when symptoms significantly affected their lives, two-thirds of respondents indicated that symptoms are either persistent or that they’ve had more than ten discrete periods. You can see what the results showed in the survey. So, in our next polling question, we want to understand how you manage the symptoms. We’re going to do that with just one more polling question.

During the time when symptoms impacted your life, what, if any, adjustments did you make to your management approach? Choose all that apply. A: Increased peer support. B: Increased talk therapy. C: Worked with my clinician to change my medication therapy. D: Worked with my clinician to incorporate or change medical devices such as TMS, neurostimulation, electroconvulsive therapy. E: Made changes to my diet, sleep schedule, physical activity, meditation, mindfulness, or other non-clinical approaches. Facilitator: I didn’t do anything different. G: I don’t know. H: Other.

Okay. What I want to do now is delve into this a little bit by talking to you all in the room and giving you all a chance to comment on it. DBSA staff have the microphones. If you’re participating by the web broadcast, type your comment in to the comment section.

To start, I’d like to focus on the top two responses. So let’s work with “Made changes to your diet, sleep schedule, physical activity, meditation, mindfulness, or other non-clinical approaches.” How did you do that? Anybody who answered that, if they’d like to comment on it.

Male Speaker 1: Starting in January of this year, I really started to try to incorporate as many different holistic approaches as I could to try to keep myself balanced. So: meditation, yoga, my diet—I went from virtually vegetarian to almost entirely vegetarian. Essentially, if it’s made somebody else feel better, or if it’s worked for somebody else, I’m willing to try it. Because as somebody who manages bipolar disorder, there hasn’t been an antidepressant that has worked for me whatsoever. I only take a mood balancer. So I have to turn to these other methods to try to keep myself as happy as possibly can be. And it’s worked really well for me. It takes a lot of effort, and you have to keep on adapting and

● ● ● ● keep on putting things into your daily routine to do it. But it’s really been the only effective treatment for me as far as depression goes.

Facilitator: Good that it’s been effective. We have one right here.

Lucinda: Hi. I’m Lucinda from DBSA Boston and DBSA National. I find it really telling that so many people, following on the previous speaker, take on lifestyle changes and other practices. And personally, actually doing all of those things, and probably also being post-menopausal—I also have experienced mania and depression—I take very little medication. And I only take medication because I promised my parents I would, and it’s an integrity issue. And my psychiatrist and I have virtually gotten it down to nothing.

The other concern that I have in terms of our conversation today—and it may not fall in within the bounds of the FDA—but there was an article recently in the New York Times in the last week or so that pointed out—it’s called “What’s Life Like After Depression? Surprisingly Little Is Known.” And there are actually people, as you saw in even our data—who I’m assuming are mostly people who have depression or are affected by it negatively most often—are the ones who answered our survey. But there are people that actually do not have it forever. And the fact that we have no data on them, longitudinally or otherwise, is, I think, a great omission.

And coming from DBSA, where we have a strengths and resiliencies model for living with mood issues—it’s a place that I think the medical model needs to go. Because if we could understand why some people are able to either get over depression or live with symptoms or live well with symptoms or without symptoms, we need to know what contributes to that. And perhaps if we knew what contributed to them, we’d be able to create protocols that would help people that are at the effect of it most often. Thank you.

Female Speaker 2: You asked about making changes to diet, sleep, etcetera. And I know for myself, when I feel sort of that undertow coming on, those are things within my control that I can do on my own before I can get to a therapist or my doctor or get in on some of the other things. So that’s kind of my first line of response. And I wonder, in terms of therapeutic intervention trials, how much those things are controlled for given that it’s the biggest bar, and it may not be anything that is being necessarily monitored or collected as you’re looking at whether another type of therapy is effective or not. And it could be differences that are occurring in some of those other things that we’re not even asking.

Facilitator: That’s a very interesting point about how do you control for that fact that while at the same time you may be starting a new medication, you could be doing a

● ● ● ● lot of other things too. I think we heard Patrick talk about what a big difference it made when his daughter altered her lifestyle and sort of took responsibility for making sure she got enough sleep and was eating well and things like that, and how that affected it.

Female Speaker 3: Hi. [Lajean Bailey 12:17] from DBSA National. I’m a family member. My brother died when I was 18 and I walked in on a suicide attempt from my parents. So one of the things that I know—that fever of unbelievable hypervigilance that creates a level of anxiety in a caregiver. I have been a 20-year meditation practice person, and have gone with meditation techniques that have scientific validity. And mindfulness, MBSR, looking at other forms of meditation, iRest— extremely, extremely helpful in managing that level of hypervigilance, both in patients and caregivers. I always say I have a three-day half life for meditation— if I don’t do practices that make a difference every three days. It helps abate any of that hypervigilance. It’s very, very important.

Also, diet and exercise—critical to bathe the brain in things that are going to give neural resilience.

Facilitator: Thank you very much. I think that several of you have shown the world that peer support, family members, and others help you in making decisions about how you might manage your condition. Go ahead.

Barry: I’m Barry. I’m a family member. And one of the things I’ve observed is that when someone’s in deep depression—just getting out of bed is virtually impossible—I’ve observed that sometimes there are techniques that people use that are probably not super healthy to jump start or knock them out of that. For example—it sounds bizarre—but hitting one’s head against the wall or against the floor creates a pain response that generates some sort of stimulation that has helped get them off their feet and moving. So, from a therapy development perspective—because exercise, diet, all that requires motivation that depression itself saps you of—it’s a nice idea, but it doesn’t work if you can’t do it.

So from a therapy development perspective, my idea is I wish that we could have something that could help jump start or get us out of that moment so that we can get to a spot—even if it’s just a temporary thing—get to that spot where they can then get back into a healthy routine. And I think there are other conditions where there’s a similar kind of concept, where if the patient is not doing well, clinicians will infuse a drug for an immediate response to get them back to a point where they can then treat them better. Obviously, there’s a potential for abuse if it’s something that super effective at picking you up. But that, to me, seems like a big hurdle for depression, because it’s just got this momentum that’s hard to get through.

● ● ● ● Facilitator: That relates to a question of: How concerned are you that you’re going to reach a point in your life where you’re unable to manage your symptoms, nothing’s going to work, and you will not be able to achieve the outcomes that you desire? Have you ever experienced that? Are you concerned that you’re going to get to that point?

Female Speaker 3: It’s me again. For me, increased peer support—where that comes in is twofold. When I’m in a bad place, so to speak, I tend to increase the amount of peer support that I offer to others. This helps me tremendously. It gets me out of that place in my head. It gets me where I can take the energy—I find the energy in myself to lend that energy to somebody else that is in a worse place than I am, if we want to use those terms.

So that’s one of the most important things that I’ve learned over the years, is to get out of my hole and to offer to somebody else what I’ve learned over the years. That by reaching out to others, even when you think you don’t have it in you—you don’t know, there might just be one word that you offer to somebody else, and that one word could be that turning point for them. And that one word could just be “care” or “I care.” That’s what I do.

Facilitator: Thank you very much. That’s a very powerful message to hear, I think, for everyone in the room. Does anybody have anything else? Because I have one more question, but then we have to move on.

I just want to note: Does anybody see any options for managing depression that are not on the list or that you’d like to see developed?

Female Speaker 4: This may not speak directly to that, but with this age of drug abuse and addiction and all those things—I have insomnia. It is just so bad. And when I don’t get enough sleep, then I’m not able to deal with all my other symptoms. But my doctor has told me he must cut me back on Ambien because it’s not a good drug to be taking, or he gets more points or something for taking his patients off the medications like that that could be addictive. Over the years, I’ve tried almost everything. I do meditation. I get out of myself. I do peer support. I do all those things. But the insomnia is real. It’s not just you don’t go to sleep at night. And something that will help us sleep or not to worry about becoming addicted.

Facilitator: Thank you. I think several people have mentioned sleep disorders in various forms. Whether you sleep really affects how you feel and your overall health, I think.

● ● ● ● So I’d like to move on now to the next one. I want to talk in some more detail about some of your unmet needs. I think that one of the most important aspects of this is: What are your unmet needs and what would you like to see in terms of treatments, particularly treatments that drugs could be used to address? So, as you can see, some of the other aspects of wellness that were important to peers responding to the Supporting Wellness Survey included: having a purpose in life, getting through the day, self-acceptance, follow- through on ideas and intentions, calm relaxed presence.

So, given that the survey respondents shared that this list represents important aspects of wellness, we’d like to understand why some of these aspects are important and how you would personally evaluate whether or not you’re attaining wellness within these aspects. First of all, I’m going to start with “getting through the day.” Some of the respondents to the survey stated that getting through the day was an important domain of wellness. What does that mean to you? How would you describe it? And can you give some examples of what it means just to get through the day? Anybody? There you go, Maria.

Maria: Everything fluctuates throughout the day. And between anxiety and depression, it is not uncommon for me to walk down the street and just objectively say to myself things that I see—podium, person, table, white, black, carpet—just to stay present. And that is one of my most useful tools to get to the train and not think about stepping in front of it or to get me to home, to get me to make dinner, to get me to text my friends that I love them, to get me to listen to three guided meditations that will get me to sleep.

Facilitator: Thank you. Anyone else want to address that? If not, Keith, when he was up here, shared about how it can be difficult to follow through on ideas and actions because depression had immobilized him. Anybody else have examples of that or want to share any experiences with that?

Female Speaker 5: I want to speak on behalf of my 19-year-old. He has all these great ideas and intentions. He comes downstairs and tells us he’s going to get into music management or he’s going to be the next this or he’s going to go to school to get into HVAC. And he’ll be talking, and I can see him just shut down. You can just see him just completely shut down. And I think he realizes he has this depression and he has this anxiety. And it’s all he can do—to even come down and tell me about these great ideas before he just shuts down and goes back upstairs and goes to bed.

Facilitator: What do you do? What do you do about that when he does that?

● ● ● ● Female Speaker 5: I go upstairs and I stare at him until he talks to me. I literally—he says, “Mom, I’m very uncomfortable with you in my room.” And then I bribe him with pizza. You know, pizza gets him out of bed, pizza gets him in the shower. I mean, I do the best I can do. But yeah. It’s hard to watch him just completely shut down in the middle of something.

Facilitator: [inaudible 23:35].

Female Speaker 6: I think from your [inaudible 23:39], and I’m going to speak from my family’s— my mother’s responses. I tend to be, just by nature, a big-idea thinker. And I like broad policy and all those kinds of things. And when I have this conversation, my mother goes, “Is that your mood disorder?” And I find that very often—and I’m sort of a Bill Clinton—I just talk out loud. And so I come up with an idea that sort of things fall together. And very often, I find that it’s almost like, “How dare you?” You know, “You’re getting sick. This must be [inaudible 24:21] about being sick.” When in actuality, it’s about being well. And every idea anyone has doesn’t mean it’s going to happen.

But to be able to brainstorm out loud and even this idea of getting through the day—you know, some days I can make my commitment and some days I can’t. And I talk to my support system and say, “How are you feeling today?” They’re like, “It sucks. It’s Monday and it’s raining.” You know? And that’s a normal response. So I think that that idea of the follow-through—I often have to check in with other people to say, “How are you feeling?” To see—are my feelings normal or not normal, and how much energy are you giving to your job? Is it normal; is it not normal? But yes, I find it very challenging when my mother says to me, “There’s that mood disorder again.” I love my mother.

Facilitator: There’s another couple of—over here first, and then over there.

Male Speaker 2: So you talked about your interest in being immobilized. I’m going to represent someone who is a leader and a book author whom DBSA National invited to speak as its voice two years ago at a DBSA National conference. That’s Andrew Solomon.

Andrew Solomon shared with us first that people tend to think that the opposite of depression is happiness. He said, “The opposite of depression is energy.” And that was a very powerful experience for everyone in the room. And then he followed that through with a discussion about his own immobilized state. So anyone who understands what Andrew Solomon has accomplished in his work for the New York Times and his book on depression, The Noonday Devil; on his powerful book, Far From the Tree—you know that in periods of his wellness, he’s extremely productive.

● ● ● ● And yet, what he shared with us at DBSA National that day was a conversation about how he had to call his father to help him get out of bed because it was so painful to make it to the shower and actually turn the handles. He had no energy. So I offer that to you on his behalf in what he would say about immobilized moments in depression and also what he thinks of as a better, kindred opposition than happiness.

Facilitator: Thank you. That’s very helpful.

Female Speaker 7: So thank you, everybody, for sharing the different aspects. I think one of the most helpful for me, coming out of therapy and then the mindfulness training—I always think that we don’t use brain training enough in psychiatry, other than CBT. However, mindfulness therapy and also transformational personal development courses that I take have really enabled me to separate my mind and my thoughts from who I am, and that when I act from who I am, then my mind and the thoughts that I have can just be, “Thank you for sharing you’re feeling depressed today. Thank you for sharing that you suck and the world is terrible. Brain, mind, share what you need to share, but I’m going to go out and do what I said I was going to do.”

It doesn’t sound like, “Well, how do you do that?” It’s an experiential training. And, I think you’ll find—Eckhart Tolle talked about that. He was suicidal when he had his moment of revelation. And as we all know, he’s become a spiritual master out of that.

Is everybody capable of this? I think so. I was just lucky that I found the right combination for me to be able to do that. But I don’t think it’s something that’s exceptional, and I hope someday we’re able, again, to study things of this kind to give people access to the power of their own minds to change how they relate to it. Thanks.

Facilitator: Thank you very much. That is actually a really good segue to the next topic. Before I go there, I just want to ask if anybody has any other aspects of wellness that they think should be added to the list that are not here. I think that might be important for people to hear. If there’s something—you can just make your comments very brief.

Male Speaker 3: I studied what they call imagery. And I noticed that it’s not as open as it is today. Imagery is one of the powerfulest things that helped me through my experience of depression. And I was hoping that imagery and family therapies with it could be added.

● ● ● ● Facilitator: Thank you. I think that would be one of the things that you might want added to one of the other lists of the things that people might use to manage depression. So anybody else? I’m going to take advantage of that segue into how do you measure what people are thinking in their brains to tell what the results are. So we’re going to shift gears now and get your thoughts about the scales that are being used in clinical trials to measure the effectiveness of medications.

When they are studying the potential clinical benefit of a medical product in a clinical trial, they use scales and measurement tools to assess change that might indicate how well a medicine or a device is working. Sometimes these are also used by your doctor to assess whether therapies are beneficial. And traditionally, these measures have been based on the clinician’s observations of how well a patient’s doing. So, a number of companies have collaborated to develop a new scale that FDA recently approved for exploratory use in clinical trials. Dr. Mathis, I think, and Dr. [Saxony 31:23] have also mentioned this as well in their remarks. And FDA has specifically asked us to gather your input on the aspects of depression that this new scale is designed to measure.

So I’m going to ask you some general questions about the new scale, and then I’m going to show elements of the scale and drill down a bit to get your reactions to the specific elements in the measures that they’re going to use. So we’re getting very close to the end of our time, and we’ll only have time for a few comments on these, so if you could please try and keep your answers brief.

My first question—I’m not going to turn to the scales yet. There will be two more slides that talk about the scales. But first, I want to ask this broader question: Do you see advantages to having the patient report the clinical benefit rather than the clinician doing so? And if so, why? What are the advantages and why do you think that? That’s the first question: the switch from a clinician- measured outcome to a—I’m going to use the word patient here because they would be a patient because they’re involved with a doc.

Male Speaker 4: I think it’s a mistake to phrase it as an either-or question. I’ve watched my daughter bullshit numerous therapists over the years—pardon my French. But the therapist was able to understand the help that she needed when my daughter was very capable of masking that. So I think that there really needs to be some cooperative assessment there, because it takes a certain amount of self-awareness to tell someone how you’re feeling in an effective way. And if you’re in a bad spot, you may not have that. So that may be the first thing that is important to keep in mind.

Facilitator: I think it’s a very good point.

● ● ● ● Female Speaker 8: I agree with what the gentleman just said. It absolutely has to be a combo platter of the two. But it is essential that the patient express how they’re feeling because there’s no way that the doctor can quantify motivation. And as we learned from our gathering last year, that’s really one of the big things that can show if a medication is working—is if the patient feels motivated. And when we looked at the questions that the patients were being asked last year, there didn’t really seem to be any way to judge just through those questions the motivation factor. So yeah, I do think that the patient needs to have definitely some input.

Facilitator: Go ahead.

Male Speaker 5: I can’t remember the doctor who’s the director of the center.

Facilitator: Dr. Mathis.

Male Speaker 5: Thank you. He had listed—it was hard to read—but they listed other outcome measures, I think. And one of them was a third one, which was actually other people around the patient, like family members. And the woman who mentioned she loves her mother—that might be a good thing and it could be a bad thing. In some respects, from a caregiver perspective, being the person who’s kind of tattle-taling or watching a patient or a loved one kind of like a hawk—“Oh wow. It looks like you’re not getting a lot of sleep. I better somehow report that.” That’s not necessarily a healthy relationship.

But it’s somehow capturing—there’s other people involved in it. In my case, I believe it’s a family disease. And having other people be able to kind of provide some sort of way to give feedback. Because again—to the gentleman’s point— my wife, I’m pretty sure, lies to her therapist every time they talk. Not that I want to be the guy who’s like, “No, she’s full of it,” but I think it would be good to have almost a three-way perspective on the condition.

Female Speaker 9: Yeah. I’d say everything needs to be combined. I had the problem that when I would go to doctors, and particularly new doctors, I presented very well. I was well educated on this, I had the right words to say, I made jokes. And I could not get across to the doctors how bad my depression was. And I think to some degree, especially maybe in a new situation, there might be an inclination to think that maybe I was exaggerating or something. And literally, I had been to my therapist for years before he understood, when I made—I left a voice mail for him when I was really bad. And he had not understood it, speaking to me for years.

● ● ● ● There is also the problem with reliability of self-perception, because when I would go into the psychiatrist who’d say, “How is the month?” if I was in a bad mood, I’d say, “Oh, it was awful the whole time.” If I was in an okay mood, I would say, “It was kind of bad.” And it wasn’t until I was able to go in with new charts, and we could count the number of days and count the severity, that we could understand. It wasn’t until I could go to a psychiatrist and say, “Scale of one to ten, I’m an eight,” and see the psychiatrist just be completely surprised that was my reality. So I would definitely say a combination.

Facilitator: Okay. One more, and then we’re going to get into one of the more general questions. Then we’re going to get into the scales specifically. I’m going to show you the scales, and I want to get your reactions. Go ahead, Yvette.

Yvette: I think we also need to be thinking about how people are trained. I’m a clinical social worker, and I go to a psychiatric nurse practitioner. And my treatment with her is better than my treatment has ever been with—that’s a lie. I have one psychiatrist who sort of matches her. But I had a lot of psychiatrists. But I do think we need to be thinking about other providers, be they physician assistants, other people who are in positions to prescribe meds. But also the way that they’re trained is that it’s not a fifteen in-and-out, but that it actually has a therapeutic piece attached to it. And I think we don’t think about that enough.

Female Speaker 10: Yeah. I agree with most of the comments here. Once I had a chance to look at surgical notes after surgery, and the first thing the surgeon mentioned was “She has a pleasant disposition.” And that’s just naturally my personality; I’m always smiling. But my pain was likely a ten at that point. So it’s really important to have input from everyone, including caregivers and the patient, at every given chance.

Facilitator: Thank you. Now I want to talk about the time period of observed change. And we have had several people mention that 30 days isn’t enough. We want people to look for the long term. This question is really about the time period of observed change. Traditionally, the time period of observed change is over 30 days. But the scale that they’ve developed asks the patient to reflect back only on the last seven days. So, separating out from whether you’re measuring long- term impacts or not, the issue is if you’re going to be asked, “How did you feel over the last 30 days?” where you mood may have fluctuated considerably, now they’re going to ask you to look at the last seven days.

What do you think about that? Do you think that that’s an appropriate time frame for you to look at and measure how you’re feeling?

● ● ● ● Female Speaker 11: I don’t think you can capture enough information. I’m also concerned, even in the seven days—I like the idea of having someone maintain a chart, because you just don’t remember. And whatever mood you’re in on that day that you present is going to definitely impact your overall assessment. So I think it should be certainly longer than seven days, but more of just me reporting to you looking at some sort of measure.

Female Speaker 12: So it might be a question of how often you did it. Let’s say you did it four times in a month. What did you feel for this seven days, the next seven days, the next seven days—as opposed to seeing you once a month and saying, “Oh, how did you feel over the last 30 days?”

Yvette: I do charting. And one of the things I realized with myself and also with my patients is that when they’re not charting is when I know they’re not well. So I think that we also need mindful sort of “what does that mean or not mean?” And what we think it means may actually be just the opposite of what it is.

Facilitator: Thank you. Kevin, you have something from the web.

Kevin: Yeah. Two people had mentioned online that they actually used the DBSA Wellness Tracker to be able to keep track of their moods. And another person who’s in dialectical behavioral therapy uses an app to be able to keep track of their moods and feelings. So there’s different things, different apps to be able to allow that.

Facilitator: Thank you. Thank you to the people on the web who are making comments. I think that’s helpful. Anybody else?

Male Speaker 6: I just want to bring up the problem of hospitalization in this conversation that we’re talking about now about time. I’m a senior administrator at a therapeutic day school in Manhattan. And I can tell you that the bar at the moment, medically, is if one is at immediate risk to oneself or others. That is a very low bar, and it is extremely limiting. And so, any number of really fine physicians, psychiatrists, professionals who are clinicians in New York will tell you, “Don’t go to the hospital unless you absolutely in that position because you’re going to end up going home two days later or three days later.”

This is, I think, responsive to your point. If you look at seven days, you have to understand if we’re talking about a very significant number of the people who responded to this, over 50 percent, are young adults who remember onset as adolescents. If you look at any of the indicators that you’ve already offered with regard to atypicals and many other drugs you’ve discussed, anyone who knows this world knows that it takes a couple of weeks just to find out—first just to get

● ● ● ● up to a therapeutic dose, titrating up slowly for all of the other components of risk you know. And so, there’s 14 days. And we haven’t had a chance yet to assess what we’re calling a therapeutic dose.

Facilitator: Okay. Thank you. So now, I want to move on to the specifics—a few more specifics about the new scale. So here’s a list of the dimensions for the new scale. These would be rated as: not at all, a little bit, moderately, quite a bit, and extremely. So the question is: What do you think about these questions and the way they would be measured in terms of reflecting how well you’re doing and how well they would be likely to reflect any change in how you’re feeling as a result of a new medical product?

Take a minute. Take a look at the list. And again, each one you would rate as: not at all, a little bit, moderately, quite a bit, and extremely. Think about if somebody put that in front of you or was asking you these questions and asked you to rate them, how would you feel about whether they would reflect how well you’re doing? And whether they would reflect any change that you might be feeling if you had just started to take a new medication?

Female Speaker 13: This list overwhelms me. And if I, today—whatever day this is—if I say, “Okay, the last seven days,” that’s until last Saturday. Well I was sad on Thursday, I was hopeless on Friday, I was irritable most of those days. I have a very difficult time figuring out which of these might be the most important for me to report on. Now. If you could give me—and Yvette’s going to give me such a thing—a chart that every day I could say, “I’m not very hopeless today. This is a really good thing.” Or, “I’m overwhelmed, but I know why, and I’m going to get over it and by the end of the day I will not be overwhelmed.”

If I can do that on a daily basis, that does two things for me. One, it gives me a record that I can then share with my practitioner. It also tells me what I need to focus on. Because if I’m overwhelmed, it’s almost always because I’ve sad yes to too many things, and I just need to back away—and then I’m not tired. So I think it has to be an ongoing thing for me. That may overwhelm other people, but for me, I have to do this every single day.

Facilitator: Thank you. Anyone else?

Male Speaker 7: I guess it also doesn’t really get at the “what people want” aspect. We just heard all about all the different things people want in all these different ways, and I guess this describes what it might feel like to have depression, but it doesn’t have a relationship to what people with depression would want based on what we’ve heard today. And I’ll always put in a plug for [inaudible 46:37] developed promise measures that has satisfaction with social roles and

● ● ● ● activities, which does kind of describe all the different domains and is computerized, adaptive, and everything—and far less overwhelming. So I think something like that could be a lot better.

Female Speaker 14: I can add to that and say when I read this list, it’s almost overwhelming in terms of the negativity. And I felt like it could be framed in the exact opposite way, and it would tell us the same thing and it wouldn’t be overwhelming to read through.

Female Speaker 13: I’m sorry. I asked to have the mike back for just a minute because I just want to do a plug. NIH does really wonderful work. PCORI, Patient Centered Outcomes Research Institute, does amazing work because everything they do is patient centered. It’s all about, “What’s the patient feeling? What’s the patient doing? What does the patient need?” And NIH is a very scientific sort of study. But I think we need a little bit of both, and I really want to say: Patient Centered Outcomes Research Institute is really focusing on patients. Thank you.

Yvette: I think question seven sucks. I agree that we should be coming from an asset- based perspective, and if I’m thinking about my problems—my friends have more financial problems that I do. And I’m constantly testing against other people, sort of how they feel, what’s going on, can you concentrate, what’s happening, are you overwhelmed—so I absolutely agree that we need to be thinking about flipping this to an asset-based perspective. But also asking ourselves the question—and this is the fun one—what is normal? And what is part of mood disorder?

Facilitator: Okay. We have one more I think we can only do—

Female Speaker 15: It’s a quick one. Once again, the word “motivation” is missing from this list. When you’re depressed, you’re unmotivated. And so maybe if we could add one more, number 10 could be: how motivated were you today?

Yvette: I was going to say: uncompleted tasks.

Facilitator: Okay. One other?

Female Speaker: Energy and resiliency.

Facilitator: Okay. That’s great. Thank you very much. I’ve got another list for you—

Female Speaker: The one last thing I just wanted to add that sort goes to that is flatness. I think that’s huge.

● ● ● ● Facilitator: Okay. All right, so here’s the second list of dimensions for the new scale. More— there’s 10, 11, and 12—so we’d have to add the others as 13, 14. The whole list. So these would be rated as: never, rarely, sometimes, often, and always. What do you think about these questions in terms of reflecting how well you’re doing and how well they’d be likely to reflect any change in how you’re feeling as a result of a new medical product? I guess we don’t have to repeat the same comments about “they’re negative; they’re framed in the negative,” so we can skip that.

Female Speaker 3: So, I’ve never met anyone that feels like doing nothing. I think with depression, you feel like doing something all the time, and the question is: can you? Or blaming yourself when bad things happen? You know, I think it’s really important to look at both sides of the experience.

Facilitator: I’d like to ask if anybody—whether these dimensions that are here matter to you? Are some of them more important than others? Going back, I guess the question really goes to both List One and List Two. Are there any here—if they were written differently, which do you think would be the most important to you? Go ahead.

Female Speaker 16: Yeah—the second slide. So I don’t know if you have consulted with any eating disorders group, but that may be triggering, just asking about overeating. Perhaps saying, “Do you have increased appetite” or something—I’m not sure. But that could be triggering.

Facilitator: So, “overeating” might suggest that it’s a bad thing, and someone with an eating disorder would react in a problematic way to that.

Female Speaker 17: I noticed it, especially with those two, 11 and 12—they’re value judgments. They’re poor, and they’re not even balanced. Have you had a meal? Have you not eaten anything? Have you eaten everything? I mean, something where it’s not you’re deciding, “Oh, I’m being bad” or “I’m being good.” But I think the sleeping one also would be helpful more towards the front than towards the back.

Facilitator: Well, it relates to six: “Over the past seven days, how tired have you felt?” Sort of relates to the sleep thing. Go ahead.

Yvette: I was just going to say, number 15—it might not be “blame yourself.” It could be blame yourself when bad things happened, or it could be blame yourself because you are the bad thing. You know—I’m not saying say it that way. But I do think that at times, it’s about “if I was not the problem.” So we’ve got to

● ● ● ● figure out how to word it differently. But I think that that’s a question that could be helpful.

Facilitator: Kevin has some comments from some people on the web.

Kevin: So the challenge that one person has online is not with the questions, but with the period of time. They’re saying that depression is cyclical. So they could have a good period for seven days, and then after that, day eight, they could be doing really bad. So it’s the period of time that they have an issue with.

Facilitator: Okay. Over here.

Female Speaker 18: I just wanted to comment. Basically 13, 14, 15, 16. I recently moved. It’s been about three years, from Maryland to Pennsylvania. Needless to say, my upstairs is still in boxes. I find it very difficult, and I do have to push myself to get things done. Maybe it’s more that I’m just not happy where I’m at, but the majority of the evening when I’m home alone, I don’t feel like doing anything. And the rule of thumb I try to follow is just keep moving forward. Just keep moving forward, and you will be okay.

Facilitator: Thank you very much. We have one more over here. I think this will be the last comment. Shelby has a comment. Okay. I’m too soft. One here, and if not over there, then Shelby.

Female Speaker 19: I’m just wondering with this, looking at this list—is this a list of things that we’re going to keep to ourselves, or would we share this with others?

Facilitator: I don’t know the answer to that. I think it would be a scale that would be used if FDA would like to [inaudible 54:54]. The mic’s not on?

Female Speaker 20: There are a couple of context pieces that may be helpful for you all. This instrument was developed with input from patients throughout the development. So this was not a clinician-driven instrument. This was from patients, so there was some thought there. The idea is this is to be used in a clinical trial setting, so I think the question about would something be actionable based on your response—I think it’s really to be used to support an end point in a trial. So that’s one thing. And this is something that would be provided in a trial design multiple times, so it’s not like an instantaneous “how are you today? Or in the last seven days?” You would be getting it on a cycled basis so to be capturing my good weeks, my bad weeks, my in-between weeks. So the idea is to be used through a duration of a trial, and that aspect.

● ● ● ● Facilitator: Thank you so much for clarifying that. I think that’s helpful. Shelby, do you have something—?

Female Speaker 20: So the question is: Is there a daily diary concept of this? So actually that is a concept that is being explored right now. As we speak, the group that has developed this is looking into a daily and a now concept of how to use just what they’ve done, a leverage, and then add what is needed to measure within 24 hours, and then what is right now—because we do realize that those are important concepts as well.

Facilitator: Shelby’s going to have the last word.

Shelby: I just wanted to add one little thing because a lot of these are important—but for me, when I am struggling with my depression, I isolate myself from social relationships and I avoid commitments. And I didn’t see a question address that. Because when I’m feeling myself falling into that deep, dark hole, I notice that I don’t call my friends. I don’t go out in public. So, social interactions are decreased. So I think that would be important to add, maybe.

Facilitator: Okay. Thank you very much. That really brings us to getting close to the end of the program. I want to thank everybody here, the panelists and everybody here, for your participation and your comments. I’m sure that the active listeners in the room have found this to be invaluable.

Michael, Facilitator: Thank you, Jane. I think I can speak for all of us that we’ve all learned a lot today. I do want to thank the peers who spoke today: Alison, Shelby, Elli, Christie, Beth, Keith, Sinuet and Patrick. It takes immense courage to publicly share your journey and all of us are extremely grateful. I also want to thank Dr. Mathis, Dr. Sacks for your comments today; shortly, we’ll all hear from Dr. Campbell, so thank you in advance. I’d like to take a few minutes to review what we’ve learned today and share some of the specific aspects to our active listeners in the room: the FDA staff, the medical product developers, and the researchers.

Depression as a condition: one of the messages we heard today is that people experience depression as a condition and not a label. Alison said, “I have a mental health diagnosis. I am not my diagnosis. Keep the whole person in mind when developing solutions for patients.” Our first ask is: can medical product development examine alternative categories or simply show results specifically by different levels of severity?

● ● ● ● We also heard depression is a chronic condition of personalized outcomes. Yvette mention: hormonal changes a woman experiences throughout the course of her lifetime and the way that might affect efficacy, the possibility of negative side effects. Our ask is: can trials report the conditional probability that a person will respond to a new drug based on their response to a prior medication? Can trials report on outcomes over sustained meaningful periods rather than at Week Six or Week 12? Can trials include one patient’s centric life satisfaction measure all major depressive disorder clinical trials? Can trials make information available post-marketing programs? Better is not well.”

Keith said: he desired more than just being okay, he deserves happiness and mentioned the potential of testing for genetic and genomic markers to help improve peoples’ lives. This past September, Commissioner Gottlieb while speaking at the Friends of Cancer Research Blueprint for Breakthrough Forum stated, and I quote: “The FDA must be flexible and open-minded to new approaches that best meet the needs of patients so the patients can have confidence in the results and the treatment that comes from it. Can medical product developers be rewarded for innovative research and development but seeks new thinking about the natural history of major depressive disorder.”

Whole health: the importance of treating whole health. We heard from Yvette, Shelby, Sinuet and Keith about experienced depression with a co-occurring disorder. Can trials collect basic mental outcome measures from people experiencing comorbidity: PCOS, sleep apnea, COPD, diabetes, cancer, heart disease, and others? Thank you for giving these requests your best consideration. Your input is extremely valuable. It assists us in continuing our initiative to transform the definition of wellness for people living with mood disorders. Today’s meeting has been recorded. Our next step would be to review the output from this meeting and write a post-meeting report that will be made available to the public. We will be publishing that report early 2019.

Before I turn the meeting over to our last speaker, I want to thank everyone for participating today. Your insights have been very revealing. I also want to thank those that provided much counsel and guidance throughout this process: Hugh McCleary of Gift Collective, and our facilitator, Jane Axelrod. We are grateful for your support, patience, and excellent advice throughout this entire planning process and throughout the day today. I also want to thank the DBSA staff who made today possible, especially Phyllis Foxworth, for her passion and commitment to ensuring the voice of peers are represented soundly throughout this discussion. Thank you, Phyllis. Jane, back to you.

Jane Axelrod: My last job of the day is to introduce Dr. Michelle Campbell, who you heard from just a minute ago. Now I’ll tell you who she is. Dr. Campbell is a social

● ● ● ● scientist who works on the FDA’s clinical outcomes assessment staff in the Center for Drug Evaluation and Research in the Office of New Drugs. She’s participated in several recent FDA workshops on methods to collect clinically meaningful patient experience data. Her and her staff provide consultation on development, validation, and interpretation of clinical benefit endpoints in clinical trials to support drug development, labeling, and promotion. Dr. Campbell is going to share with us what she found productive and informative about this afternoon’s meeting and how FDA is going to use this information.

Dr. Michelle Campbell: Thank you Jane. I want to thank you, Michael, for those great remarks. First of all, what a great meeting? We have all learned a lot. I know during the break, myself and my FDA colleagues, kind of gathered around and we’re talking about what we’ve already heard first before our break and we’ve learned even more the second part of the day. I want to first thank all of the panelists today for gaining the courage to come up and talk and express to us your experiences with depression and other comorbidities that you may have to find that balance between every day. I also want to thank all of you for attending in person. For those on the web, again it’s great to see that the caregivers who are here and the perspectives that they provided as well as industry members, other patient advocacy groups, and patient support groups as well.

A special thanks to the depression and bipolar supporter lines and all of your staff who was involved in planning this meeting. I want to tell you: we hear you. Your thoughts and comments were highly informative. We’ll take this perspective back to us at the FDA. I’ve attended other patient-focused drug development meetings and I can tell you these meetings are very informative. Particularly, as Dr. Mathis said earlier today, we really do take back what we hear and we incorporate it into our work. Some of the key things I heard today, throughout our discussions, was the concept of thrive; and is that something we need to examine as an outcome?

I heard that: I am not a diagnosis. I am bigger than my diagnosis and that we need to find a way to define what quality of life is. We need a better integration of health care providers in the health care system because why do I have to connect the missing pieces to my providers? That I am the total person and not one individual piece. I heard a lot of the use of social networks, the pros and cons of that, but really have a good supportive nature. Also, a big theme I heard today, was under employments and the impacts of that. But in terms of medical product development, I heard that you’re wanting more than just being okay; and that this trial and error of trying medications is hard and we need to do better as other advances in different disease areas has processed.

● ● ● ● I heard also that there is a fear of one day the medication that is working is no longer going to be efficacious and that fear of having to start over again or having to experience side effects that because of a dosing increase be able to get back to that state of “I’m okay”, which we know we need to improve on. That there is a balance that you consider and take when making treatment decisions of the trade-off of feeling bad versus feeling nothing because of the medications. There was a lot of discussions of comorbidities with depression and bipolar and how that can impact treatment making decisions.

“Not working well enough. We need something better”; I heard repetitively, over and over again, is that we want something better and how to determine what treatment will work in what patients is at the crux of everything. We hope that there is a hope that we can try to figure out how we can incorporate that into medical product development.

At the FDA we share the patients’ communities’ commitment to facilitate development of safe and effective medical products for depression and bipolar. The FDA promotes and protects the public health by evaluating the safety and effectiveness and quality of new products, but we do not develop medical products or conduct clinical trials. It is however the FDA’s responsibility to ensure that the benefits of a product outweigh the risks; and therefore, having this kind of dialogue is extremely valuable for us because we’re hearing what patients care about and how can helping us find the way to facilitate the best medical product development for depression and bipolar and understand how the patient views the benefits and risks of their views for depression.

Once again, we are all here today to hear the voice of the patient. I thank you again for your participation. We are grateful for each of you for being here sharing your stories, experiences and perspectives. Thank you and I wish you all safe travels.

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