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Study Protocol New York State Psychiatric Institute Institutional Review Board November 30, 2016 To: Dr. Jonathan Stewart From: Dr. Edward Nunes, Co-Chairman Dr. Laurence Greenhill, Co-Chairman Subject: Approval Notice Your protocol # 7361entitled: ARE BRIGHT LIGHTS AND REGULATED SLEEP EFFECTIVE TREATMENT FOR DEPRESSION? Protocol version date 11/30/2016 and consent forms have been approved by the New York State Psychiatric Institute - Columbia University Department of Psychiatry Institutional Review Board from November 30, 2016 to November 20, 2017. (Reviewed at the Full Board meeting on November 21, 2016.) Consent requirements: Not applicable: 45CFR46.116 (d) alteration of consent to obtain verbal consent for the telephone interview √ Signature by the person(s) obtaining consent is required to document the consent process Documentation of an independent assessment of the participant’s capacity to consent is also required. Approved for recruitment of subjects who lack capacity to consent: √ No Yes Field Monitoring Requirements: √ Routine Special: ___________________ Only copies of consent documents that are currently approved by the IRB may be used to obtain consent for participation in this study. A progress report and application for continuing review is required 2 months prior to the expiration date of IRB approval. Changes to this research may not be initiated without the review and approval of the IRB except when necessary to eliminate immediate hazards to participants. All serious and/or unanticipated problems or events involving risks to subjects or others must be reported immediately to the IRB. Please refer to the PI-IRB website at http://irb.nyspi.org for Adverse Event Reporting Procedures and additional reporting requirements. Cc: RFMH Business Office (grant) Encl: Independent Evaluator, CF, cover sheet, adherence, questionnaire, HIPAA EN/LG/alw Signed copy on file at IRB v. 11/15/13 Protocol Summary Form 7361 Stewart, Jonathan Protocol Title: Version Date: Are bright lights and regulated sleep 11/30/2016 effective treatment for depression? Protocol Number: 7361 First Approval: Clinic: 11/30/2016 Depression Evaluation Service Expiration Date: Not yet accepted Contact Principal Investigator: Co-Investigator(s): Jonathan Stewart, MD David Hellerstein, MD Email: [email protected] Telephone: 646-774-8070 Research Chief: B. Timothy Walsh, MD Cover Sheet Choose from the following that is applicable to your study I am submitting a new protocol Division & Personnel Division What Division/Department does the PI belong to? Therapeutics Within the division/department, what Center or group are you affiliated with, if any? Depression Evaluation Service Unaffiliated Personnel List investigators, if any, who will be participating in this protocol but are not affiliated with New York State Psychiatric Institute or Columbia University. Provide: Full Name, Degrees and Affiliation. None Page 1 of 19 Protocol Summary Form 7361 Stewart, Jonathan Procedures To create the protocol summary form, first indicate if this research will include any of the following procedures Psychiatric Assessment Use of Placebo or Sham Treatment Medication-Free Period or Treatment Washout Somatic Treatment or Intervention Internet-based Data Collection or Transmission Population Indicate which of the following populations will be included in this research Adults Adults over 50 Employees or Students Individuals with HIV/AIDS Research Support/Funding Will an existing internal account be used to support the project? Yes Describe internal account Any DES account from which project expenses can be drawn (specifically, light boxes, activity monitors, amber and clear goggles, and melatonin collection/analysis costs) Is the project externally funded or is external funding planned? No Study Location Indicate if the research is/will be conducted at any of the following NYSPI Other Columbia University Medical Center Facilities This protocol describes research conducted by the PI at other facilities/locations Yes Other Facilities Other Facilities Type in location(s) Page 2 of 19 Protocol Summary Form 7361 Stewart, Jonathan 3 Columbus Circle Lay Summary of Proposed Research Lay Summary of Proposed Research Research Question: Is Chronotherapy (i.e., missing a night of sleep, shifting sleep time and bright morning lights to adjust the biological clock) effective treatment for non-bipolar depression? Antidepressant medications do not result in quick remissions and they produce side effects. "Jet lag" can be thought of as resulting from the internal clock being out of sync with external time; as the internal clock aligns with sun time, the symptoms of jet lag lessen. Preliminary data suggest some depressed patients act as if their internal biological clock is out of sync with the outside world and re-aligning their clock with the timing of sunlight lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may produce remission during the first week of treatment while causing minimal problems. This study aims to demonstrate the efficacy of chronotherapy by comparing its efficacy to an alternative protocol we consider unlikely to produce the same effects. Whether a given patient will be instructed to use chronotherapy or the alternative protocol will be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to determination of which protocol a patient will follow, each patient will declare their desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific times to sleep and sit in front of bight lights wearing clear (Chronotherapy) or amber (alternative protocol) goggles. Those assigned Chronotherapy will miss a night of sleep while those in the alternative protocol will not; assigned sleep times will also differ between groups using different strategies to shift the timing of their sleep from their ideal sleep time as determined by their MEQ score to their desired sleep time. All subjects will be rated daily by telephone for the first week after their Wake Night (those assigned Chronotherapy) or for the first week following randomization (those assigned the alternative protocol), and then weekly for an additional five weeks. Whenever possible, weekly visits will be in person, although telephone visits will be allowed. All subjects will be rated at baseline, 1 week and 6 weeks by an Independent Evaluator blind to treatment assignment. After the six week post-randomization evaluation, all subjects will be offered six months of continued treatment and be rated monthly. Treatment during this six month period may consist of Chronotherapy or conventional antidepressants as the patient and doctor determine. Standard ratings of depression, over-all illness and functioning will be obtained; melatonin, sleep logs and activity monitoring will measure the timing of the biological clock. Change in the symptom measures will determine whether chronotherapy is as effective as, less effective than or more effective than the alternative treatment. Chronotherapy will be judged effective if it is more effective than the alternative treatment. Secondary analyses will analyze timing of melatonin rise, timing of sleep and activity to determine whether the timing of the biological clock changes, and if so whether clock changes correlate with improvement. Measures of functioning will determine whether functioning improves coincident with, independent of or subsequent to mood improvement. Background, Significance and Rationale Page 3 of 19 Protocol Summary Form 7361 Stewart, Jonathan Background, Significance and Rationale While chronotherapy (variously including some number of nights without sleep coupled with early morning bright lights and set times for sleep with or without an advance in the timing of allowed sleep) has some degree of acceptance as effective treatment for affective disorders, the majority of the literature addresses bipolar illness. We found three studies that address depressed patients who do not have bipolar disorder. One concluded that chronotherapy is more effective for and is more quickly effective in depressed patients with bipolar disorder than those without a bipolar history, but conclusions as to whether this treatment is effective for nonbipolar patients cannot be made as there was no comparison condition (Barbini, 1998). Two studies (Martiny, 2012; Sahlem, 2014) included nonbipolar depressed subjects but neither separately reported response by polarity, although one stated that the nonbipolar subjects' response "did not differ". Both, however, also gave patients standard antidepressant treatment; i.e., chronotherapy was used as an add- on or augmentation rather than as the only treatment. Thus, Chronotherapy for nonbipolar depression appears to us to be insufficiently studied to judge its efficacy in this population. Our preliminary work (IRB #5491 and #6938) suggest our version of chonotherapy may be effective alone for nonbipolar depression. To date, we have treated 18 such patients; 10 (56%) were remitted at 1 week and 10 (56%) were remitted at 6 weeks. These results compare favorably to antidepressant medications. Szegedi (see uploads), for example, compiled data from 41 randomized, controlled trials; no drug resulted in increased remissions at week one relative to placebo. Rapidly titrated mirtazapine resulted in significantly more remissions than placebo at week 2 (13% vs 7%), while all other drugs including usual dose mirtazapine, venlafaxine, selective serotonin re-uptake
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