December 18, 2014 Use of Antidepressants in Bipolar
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Olanzapine Versus Divalproex Sodium for the Treatment of Acute Mania and Maintenance of Remission: a 47-Week Study
Article Olanzapine Versus Divalproex Sodium for the Treatment of Acute Mania and Maintenance of Remission: A 47-Week Study Mauricio Tohen, M.D., Dr.P.H. Objective: Few double-blind trials have was significantly greater for the olanzapine compared longer-term efficacy and safety group. Median time to symptomatic ma- Terence A. Ketter, M.D. of medications for bipolar disorder. The nia remission was significantly shorter for authors report a 47-week comparison of olanzapine, 14 days, than for divalproex, olanzapine and divalproex. 62 days. There were no significant differ- Carlos A. Zarate, M.D. Method: This 47-week, randomized, ences between treatments in the rates of double-blind study compared flexibly symptomatic mania remission over the 47 Trisha Suppes, M.D., Ph.D. dosed olanzapine (5–20 mg/day) to dival- weeks (56.8% and 45.5%, respectively) and proex (500–2500 mg/day) for manic or subsequent relapse into mania or depres- Mark Frye, M.D. mixed episodes of bipolar disorder (N= sion (42.3% and 56.5%). Treatment-emer- 251). The only other psychoactive medi- gent adverse events occurring significantly Lori Altshuler, M.D. cation allowed was lorazepam for agita- more frequently during olanzapine treat- tion. The primary efficacy instrument was ment were somnolence, dry mouth, in- the Young Mania Rating Scale; a priori creased appetite, weight gain, akathisia, John Zajecka, M.D. protocol-defined threshold scores were and high alanine aminotransferase levels; ≥20 for inclusion, ≤12 for remission, and those for divalproex were nausea and ≥15 for relapse. Analytical techniques in- Leslie M. Schuh, Ph.D. -
Keynote Address Stress, Sex and the Hippocampus
You are here: Home > research > 12th Research Day > Keynote Speaker ABSTRACT: KEYNOTE ADDRESS STRESS, SEX AND THE HIPPOCAMPUS: FROM SERENDIPITY TO CLINICAL RELEVANCE Bruce S. McEwen, PhD Lab Neuroendocrinology, Rockefeller University, New York, NY The hippocampal formation, which expresses high levels of adrenal steroid receptors, is a plastic brain structure that is important for certain types of learning and memory. It is also vulnerable to insults such as stroke, seizures and head trauma. The hippocampus is also sensitive and vulnerable to the effects of stress and stress hormones and it is responsive to the actions of sex hormones as well, both during development and adult life. Stress and sex hormones regulate 3 types of structural plasticity in the adult hippocampus: synaptogenesis, reorganization of dendrites, and neurogenesis in the dendrite gyrus. Developmentally-programmed sex differences are also seen in the hippocampus. Suppression of dentate gyrus neurogenesis and atrophy of dendrites of hippocampal pyramidal neurons are produced by chronic psychosocial stress, involving the actions of adrenal steroids acting in concert with excitatory amino acid neurotransmitters. As far as we can tell, these changes are reversible as long as stress is terminated after a number of weeks. However, there are also reports that much longer durations of psychosocial stress leads to permanent loss of hippocampal pyramidal neurons. In the human hippocampus, MRI studies along with neuropsychological testing have revealed memory impairment and atrophy of the whole human hippocampus in some individuals as they age. This is reminiscent of individual differences in aging in rodents, which appear to reflect life-long patterns of stress hormone reactivity that are developmentally programmed, although a developmental influence upon human individual differences is only a matter of speculation. -
Neuropsychology of Childhood Epilepsy Advances in Behavioral Biology
NEUROPSYCHOLOGY OF CHILDHOOD EPILEPSY ADVANCES IN BEHAVIORAL BIOLOGY Editorial Board Jan Bures Institute of Physiology, Prague, Czech Republic Irwin Kopin National Institute of Mental Health, Bethesda, Maryland Bruce McEwen Rockefeller University, New York, New York Karl Pribram Radford University, Radford, Virginia Jay Rosenblatt Rutgers University, Newark, New Jersey Lawrence Weiskranz University of Oxford, Oxford, England Recent Volumes in This Series Volume 37 KINDLING 4 Edited by Juhn A. Wada Volume 38A BASIC, CLINICAL, AND THERAPEUTIC ASPECTS OF ALZHEIMER’S AND PARKINSON’S DISEASES, Volume 1 Edited by Toshiharu Nagatsu, Abraham Fisher, and Mitsuo Yoshida Volume 38B BASIC, CLINICAL, AND THERAPEUTIC ASPECTS OF ALZHEIMER’S AND PARKINSON’S DISEASES, Volume 2 Edited by Toshiharu Nagatsu, Abraham Fisher, and Mitsuo Yoshida Volume 39 THE BASAL GANGLIA III Edited by Giorgio Bernardi, Malcolm B. Carpenter, Gaetano Di Chiara, Micaela Morelli, and Paolo Stanzione Volume 40 TREATMENT OF DEMENTIAS: A New Generation of Progress Edited by Edwin M. Meyer, James W. Simpkins, Jyunji Yamamoto, and Fulton T. Crews Volume 41 THE BASAL GANGLIA IV: New Ideas and Data on Structure and Function Edited by Gérard Percheron, John S. McKenzie, and Jean Féger Volume 42 CALLOSAL AGENESIS: A Natural Split Brain? Edited by Maryse Lassonde and Malcolm A. Jeeves Volume 43 NEUROTRANSMITTERS IN THE HUMAN BRAIN Edited by David J. Tracey, George Paxinos, and Jonathan Stone Volume 44 ALZHEIMER’S AND PARKINSON’S DISEASES: Recent Developments Edited by Israel Hanin, Mitsuo Yoshia, and Abraham Fisher Volume 45 EPILEPSY AND THE CORPUS CALLOSUM 2 Edited by Alexander G. Reeves and David W. Roberts Volume 46 BIOLOGY AND PHYSIOLOGY OF THE BLOOD–BRAIN BARRIER: Transport, Cellular Interactions, and Brain Pathologies Edited by Pierre-Olivier Couraud and Daniel Scherman Volume 47 THE BASAL GANGLIA IV Edited by Chihoto Ohye, Minoru Kimura, and John S. -
Antipsychotic Agents and Bipolar Disorder
Tohen and Zarate Antipsychotic Agents and Bipolar Disorder Mauricio Tohen, M.D., Dr.P.H., and Carlos A. Zarate, Jr., M.D. Antipsychotic agents have been used commonly in the treatment of bipolar disorder. This article © Copyrightreviews the evolution 1998of the use ofPhysicians antipsychotic agents andPostgraduate their role in the acute and Press, maintenance Inc. treatment of bipolar disorder. The focus is on neuroleptic drugs, the atypical antipsychotic drugs (ris- peridone and clozapine), and two of the new atypical antipsychotic drugs that were recently approved. (J Clin Psychiatry 1998;59[suppl 1]:38–48) ntipsychotic drugs have been utilized for the man- clozapine) in the treatment of bipolar disorder,4 and the A agement of patients with bipolar disorder for sev- new atypical antipsychotic drugs that have been approved eral decades. A number of alternative somatic treatments recently. approaches have been reported for patients who do not re- spond well to or who are intolerant to lithium treatment.1,2 ANTIPSYCHOTICS IN BIPOLAR DISORDER Somatic treatments other than lithiumOne reported personal to have copy a may be printed role in the management of bipolar disorder include neuro- Prior to the lithium era, the pharmacologic strategies for leptics, anticonvulsant agents (carbamazepine, valproate, bipolar disorder primarily included neuroleptics and anti- lamotrigine, gabapentin), calcium channel blockers, anti- depressants. Antipsychotic agents have been used in the depressants, cholinergic agents, adrenergic blockers, thy- treatment of bipolar disorder for close to 40 years. The use roid hormones, phototherapy, and electroconvulsive ther- of the neuroleptic drug chlorpromazine to control agitated apy.1,2 Still, in spite of all these alternatives, a proportion states was introduced by Delay and Deniker in 1952.7 Neu- of patients with bipolar disorder continue to fail or roleptic drugs then were found to be quite instrumental in be intolerant to these agents. -
Ask the Experts Forum #5: Your Position in Society
ASK THE EXPERTS FORUM #5: YOUR POSITION IN SOCIETY Nancy Adler, Bruce McEwen, and Peter Schnall address chronic stress, the wealth-health gradient, unemployment, and why women live longer than men. QUESTION #1: If wealth determines health, then why do women – who are routinely paid less than men – live longer? NANCY ADLER: First, we should note that women live longer than men but have higher rates of a number of chronic diseases. So if you actually look at what’s called “quality-adjusted life expectancy,” the gap isn’t as great. But why do women live longer than men? I think the short answer is there appear to be some biological advantages that women have, particularly estrogen, which protects women against cardiovascular disease, the biggest single cause of death in the United States. So pre-menopausally, women are protected and it shifts the mortality from heart disease a number of years. We also see a female biological advantage even at birth. Female fetuses survive at greater rates than do male fetuses, particularly if the pregnant woman is stressed, suggesting that female fetuses may have a little bit of a biological advantage. But it’s also important to think about some related issues. Wealth isn’t the only social determinant of health. If you stuff your pockets with money, it doesn’t make you healthier. It’s what money gets you, along with other social resources, that matters. And women have other resources. Education is an important determinant of health, and women are graduating from high school and from colleges at somewhat greater rates than men. -
Basic Animal Neuropsychology Session II
Third Annual Neuropsychology Research Day September 16, 2005 9:00-9:10 AM Welcome Joshua Brumberg, Ph.D., Organizer and Founder Neuropsychology Research Day Session I: Basic Animal Neuropsychology Moderator: 9:10-9:25 Morphological Characterization of Layer VI: Effect of Sensory Deprivation Eric Chen (Brumberg Lab) 9:25-9:40 VEGF and Seizures Jamee Nicoletti (Croll Lab) 9:40-9:55 Blockade of VTA Muscarinic Acetylcholine Receptors Disrupts Acquisition of a Food Rewarded Lever Pressing Task Ruth Sharf (Ranaldi Lab) 9:55-10:10 Inbred Mouse Strain Survey of Sucrose Intake Sarah Lewis (Bodnar Lab) 10:10-10:25 Opiods and Addiction Gad Klein (Kest Lab) 10:25-10:45 Questions 10:45-11:00 Coffee Break (put up posters) Session II: Basic Human Neuropsychology Moderator: 11:05-11:20 The Neural Correlates of Nodal Function During Equivalence Class Formation Lanny Fields, Ph.D. 11:20-11:35 Emotional Modulation of Attention: An Event Related Potential Study Tracy Dennis-Tiwary (Hunter College) 11:35-11:50 Mechanisms Selective for 3-D Shapes Revealed By Adaptation to Real and Illusory Tilts Andrea Li, Ph.D. 11:50-12:00 PM Questions Session III: Poster Session 12:00-1:00 PM Lunch/Poster Session Session IV: Keynote Speaker 1:00-2:30 Words of Welcome: Thomas C. Strekas, Ph.D. Dean Division of Mathematics and Natural Sciences Queens College, CUNY Introduction of Keynote Speaker: Joshua Brumberg, Ph.D. Program Head, Neuropsychology Ph.D. Subprogram Department of Psychology, Queens College, CUNY Keynote Speaker: Bruce McEwen, Ph.D. Alfred E. Mirsky Professor and Head of the Harold and Margaret Laboratory of Neuroendocrinology The Rockefeller University Stress and the Mind-Body Connection: Lessons from Neuroendocrinology 2:30-2:35 Break Session V: Clinical Neuropsychology Moderator: Peter Sturmey, Ph.D. -
Direct-To-Consumer Ads Are Misleading: Concise Statements of Effectiveness Should Be Required
California Western School of Law CWSL Scholarly Commons Faculty Scholarship 2019 Direct-To-Consumer Ads are Misleading: Concise Statements of Effectiveness Should Be Required Robert A. Bohrer California Western School of Law, [email protected] Follow this and additional works at: https://scholarlycommons.law.cwsl.edu/fs Part of the First Amendment Commons, Food and Drug Law Commons, Health Law and Policy Commons, and the Pharmacy Administration, Policy and Regulation Commons Recommended Citation Robert A. Bohrer, Direct-To-Consumer Ads are Misleading: Concise Statements of Effectiveness Should Be Required, 22 J. Health Care L. & Pol'y 209 (2019). Available at: https://scholarlycommons.law.cwsl.edu/fs/330 This Article is brought to you for free and open access by CWSL Scholarly Commons. It has been accepted for inclusion in Faculty Scholarship by an authorized administrator of CWSL Scholarly Commons. For more information, please contact [email protected]. DIRECT-TO-CONSUMER ADS ARE MISLEADING: CONCISE STATEMENTS OF EFFECTIVENESS SHOULD BE REQUIRED ROBERT A. BOHRER, J.D., LL.M.* INTRODUCTION: THE PROBLEM WITH PHARMACEUTICAL ADVERTISING The issue of required disclaimers in direct-to-consumer (DTC) advertising of pharmaceuticals boiled to the surface in May 2019, when the Centers for Medicare and Medicaid Services (CMS) published a final rule requiring the disclosure of a drug's price in DTC ads.' The idea is not a new one-the American Medical Association (AMA) adopted a resolution recommending just such a required disclosure in June 2017.2 For a number of reasons, even if the proposal is implemented it may not have much effect.3 Consumers may see price as an indicator of effectiveness, just as a high-priced car is expected to be superior to a lower-priced car, and insurance coverage may reduce patients' C2019 Robert A. -
Commentary Cariprazine in Bipolar Disorders
Commentary See article by Calabrese et al Cariprazine in Bipolar Disorders Mauricio Tohen, MD, DrPH, MBA his issue of JCP includes a report on the efficacy and duration (3 weeks) and the minimum YMRS severity safety of cariprazine for the treatment of bipolar mania score (> 20), although a minimum severity score for the T 1 from Calabrese and colleagues. Montgomery-Asberg Depression Rating Scale total score < 18 may limit the generalizability of findings in patients Key Study Findings with mixed features. Exclusion criteria were similar to those The authors report a multicenter (N = 497), randomized, of previous clinical trials as well.6 double-blind, placebo-controlled study (NCT01058668). Yildiz et al7 recently published a network meta-analysis, Patients were randomly assigned to placebo, cariprazine 3–6 with a Bayesian framework, comparing 18 active treatments mg/d, or cariprazine 6–12 mg/d for 3 weeks. The primary against placebo including the current cariprazine study outcome was change from baseline to week 3 utilizing the (NCT01058668)1 from data available from meeting Young Mania Rating Scale (YMRS). Both cariprazine groups abstracts.8 Cariprazine appears to compare well with other were statistically significantly superior to placebo on the treatments, with an effect size of 0.62 and a number needed primary outcome, all 11 YMRS single items, and Clinical to treat (NNT) of 5 for response and 7 for remission. Yildiz Global Impressions-Severity of Illness scores. The most and colleagues’7 effect size estimations put cariprazine common (≥ 5% and twice the rate of placebo) treatment- toward the top: only topiramate, risperidone, and related adverse events for cariprazine were akathisia (both olanzapine had larger effect size estimations. -
Bipolar Depression
IndicationNew Join our expert faculty for this important National Broadcast, including a live Q&A session… Bipolar Depression Please see Important Safety Information, including Boxed Presentation, Diagnosis, and Treatment Warnings, below and accompanying full Prescribing This promotional, non-CME program is intended only for healthcare professionals Information. involved in the treatment of adult patients with bipolar disorder. Date: Location: FACULTY Thursday, August 15, 2013 Novita Wine Bar and Trattoria 860 Franklin Avenue Time: Joseph R. Calabrese, MD Garden City, NY 11530 Professor of Psychiatry 6:30 PM (516) 739-7660 Department of Psychiatry Case Western Reserve University School Meeting Code: of Medicine 19064 Director Mood Disorders Program Attendees will have the option to accept the Sunovion-provided food and beverage Department of Psychiatry service, opt out of all food and beverage, or purchase their own food and beverage. University Hospitals Case Medical Center Cleveland, OH Gary S. Sachs, MD Program Objectives: Founder • Address key challenges in the diagnosis and management of bipolar depression Collaborative Care Initiative Rules: Lincoln, MA • E xplore the broader impact of bipolar depression on patients Mauricio Tohen, MD 1-• WithinP resent the relevant codeline, data thefor LATUDA, prism mustnow indicated be shown for monotherapyin and adjunctive green, even on a dark background - Professor and Chairman therapy with either lithium or valproate for the treatment of patients with major Department of Psychiatry itdepressive cannot beepisodes shown associated in white. with bipolar I disorder (bipolar depression) University of New Mexico Albuquerque, NM 2-Please The seeprism Important should Safety be 40% Information, larger thanincluding the Boxed cap Warnings, below and accompanyingheight of the full letter Prescribing A. -
It's a Golden
It’s A Golden Age Miracles happen, and emotional plasticity may be one of them. A few years ago, I met with a warm, fatherly psychiatrist to explain the science and methods of EBT. During our conversation, there came a moment when words failed me. I suggested that he try one of the tools, and he demurred, so I volunteered to demonstrate the technique. I had not been aware of how stressed I was at the time – that I feared that I would never get this method out and would go to my grave with the tools still inside me. However, in the warm womb of his comfy office, I launched into using a tool. I fired up anger that sported a few expletives, made a brief pass through sadness with tears sparkling in my eyes, next touched on fear, and then on guilt. At that point, the bottom of my reptilian brain opened up. I had unlocked a previously unconscious, completely unreasonable expectation that had taken up residence in my brain. Perfect! Moments later, I had switched that expectation to a reasonable one of my choosing, and a burst of dopamine, oxytocin, and endorphins came over me. I was in joy! All of this had taken less than four minutes. He sat quietly. I had no idea what he would say. Then he gazed straight into my eyes and said, “Nothing in my 40 years of psychiatry has prepared me to explain what I just observed.” Through his eyes, my use of the tools must have seemed strange in two ways. -
Treatment Guidelines in Bipolar Disorders and the Importance of Proper Clinical Trial Design Mauricio Tohen
Copyedited by: oup International Journal of Neuropsychopharmacology (2017) 20(2): 95–97 doi:10.1093/ijnp/pyx002 Editorial EDITORIAL Treatment Guidelines in Bipolar Disorders and the Importance of Proper Clinical Trial Design Mauricio Tohen Department of Psychiatry & Behavioral Sciences, University of New Mexico Health Sciences Center, Albuquerque, New Mexico. Correspondence: Mauricio Tohen, MD, DrPH, MBA, Department of Psychiatry & Behavioral Sciences, University of New Mexico Health Sciences Center, 2400 Tucker Ave, Albuquerque, NM 87131, USA ([email protected]). A working group led by Dr. Konstantinos Fountoulakis developed (http://clinicaltrials.gov and http://www.clinicalstudyresults. the first International College of Neuropsychopharmacology org) as well as web pages of pharmaceutical companies with (CINP) clinical guidelines for the treatment of Bipolar Disorders compounds used in bipolar disorder up to March 25, 2016. in adult patients. Their work is very thoroughly described in The authors provide a critical analysis of the existing treat- four separate papers (parts) included in this issue of the journal. ment grading methods that led them to determine that there The first article is Background and Methods of the Development was no optimal method to grade treatments for bipolar disorder, of Guidelines (Fountoulakis et al., 2017d); part 2 is Review, therefore creating their own grading system. Their methodology Grading of the Evidence, and a Precise Algorithm (Fountoulakis provides 32 different levels of recommendations, starting with et al., 2017c); part 3 is The Clinical Guidelines (Fountoulakis the optimal: “At least 1 positive 2 active arm RCT vs placebo et al., 2017a); and Part 4 is Unmet Needs in the Treatment of exists, plus positive 1 active arm RCTs, and no negative RCTs.” Bipolar Disorder and Recommendations for Future Research Lower level scenarios take into account posthoc reports, meta- (Fountoulakis et al., 2017b). -
Analyzing the Impact of Stress- a Comparison Between a Factor
Interservice/Industry Training, Simulation, and Education Conference (I/ITSEC) 2011 Analyzing the Impact of Stress: A Comparison Between a Factor Analytic and a Composite Measurement of Allostatic Load J.G. Buckwalter, A. Rizzo, B.S. John L. Finlay, A. Wong, E. Chin, J. Wellman, Institute for C reative Technologies S. Smolinski Playa Vista, C A Fuller Graduate School of Psychology {jgbuckwalter, rizzo, bjohn} @ict.usc.edu Pasadena, C A {lisafinlay, andrew wong, estherchin, johnathanweljlom@afnu,l lseter.pehdaun iesmolinski} @fuller.edu T. E. Seeman University of California, Los Angeles Los Angeles, C A [email protected] A BST R A C T Stress is possibly the hallmark characteristic of the current conflicts confronting the United States. Extended and repeated deployments require the ability on the part of war-fighters to effectively process stress in ways never before routinely encountered. Stress is well defined as a series of psychological and physiological processes that occur in response to a stressor, or the perception of stress. The physiological response to stress follows an identified path, a robust neuroendocrine response leads to responses in the cardiovascular, metabolic, renal, inflammatory and LPPXQHV\VWHPV$IWHUDVWUHVVUHVSRQVHWKHERG\¶VQDWXUDOWHQGHQF\LVWRUHWXUQWRDVWHDG\VWDWHDSURFHVVFDOOHG allostasis. If the body is not effective in returning to homeostasis, or if the environment is such that stress is repeated, markers of dysfunction may be apparent in the physiological systems that respond to stress. A method of measuring multiple biomarkers of stress responsive systems and determining who shows consistent evidence of dysfunction was developed by Bruce McEwen and labeled allostatic load (AL). AL is most frequently measured by developing a level of risk for each biomarker and obtaining an AL score for the number of biomarkers the criterion for risk is met.