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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH073797 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATSO | |||
| H-28845 |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate a possible tool for predicting future effectiveness of bright light in treating seasonal affective disorder, winter subtype, and will examine secondary effects of bright light on cardiovascular risk factors.
The winter subtype of seasonal affective disorder (SAD) is characterized by episodes of major depression in the fall and winter, with remission of these episodes in the spring and summer. SAD disrupts the lives of millions of Americans, who experience symptoms such as restless agitation, increased appetite and weight gain, and reduced energy and motivation. Bright light treatment, while shown to be effective in improving SAD in 75% of cases, only causes a full remission in 50% of cases. If doctors had a diagnostic tool to determine which patients would respond to bright light therapy, they could make better decisions about whether to prescribe bright light as treatment. This study will examine a possible diagnostic tool-a single, 1-hour bright light session-for predicting improvement in SAD symptoms over an extended course of bright light treatment. Additionally, because many symptoms of SAD (like weight gain and sedentary lifestyle) correspond to cardiovascular risk, this study will examine whether bright light treatment correlates with improved cardiovascular health.
Participants with SAD will be randomly assigned to first receive a 1-hour session of either bright light or the placebo, red light. Then all participants will switch and receive a 1-hour session of the other type of light. Red light has been accepted as a placebo in previous SAD studies because it does not suppress melatonin or shift circadian rhythms. Before and after each light session, participants will have their SAD symptoms evaluated in a clinical interview and self-report measure. After these two light sessions, all participants will receive instructions for administering bright light treatment on their own at home. For the next 6 weeks, participants will administer the bright light to themselves for 1 hour every morning. Every week they will undergo clinical interviews by phone and will mail in self-report measures, some completed daily and some weekly, to the researchers. The participants will have checkups and interviews in person on Weeks 4 and 6. At the two time periods, SAD symptoms and indicators of cardiovascular risk, such as appetite and sleep loss, will be evaluated. The participant responses to bright light and red light at the initial session will be compared with the participant responses to the subsequent 6-week treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Participants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks. |
| |
| B | Participants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light | Device | One hour of exposure to bright light daily upon awakening for 6 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD) | Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hunger questionnaire | Measured daily for 6 weeks | |
| Three factor eating questionnaire | Measured weekly for 6 weeks | |
| Sleep log |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with history of recurrent winter depression
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| Name | Affiliation | Role |
|---|---|---|
| Teodor T. Postolache, MD | University of Maryland, Baltimore | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25815263 | Background | Uzoma HN, Reeves GM, Langenberg P, Khabazghazvini B, Balis TG, Johnson MA, Sleemi A, Scrandis DA, Zimmerman SA, Vaswani D, Nijjar GV, Cabassa J, Lapidus M, Rohan KJ, Postolache TT. Light treatment for seasonal Winter depression in African-American vs Caucasian outpatients. World J Psychiatry. 2015 Mar 22;5(1):138-46. doi: 10.5498/wjp.v5.i1.138. | |
| 22277151 | Background | Reeves GM, Rohan KJ, Langenberg P, Snitker S, Postolache TT. Calibration of response and remission cut-points on the Beck Depression Inventory-Second Edition for monitoring seasonal affective disorder treatment outcomes. J Affect Disord. 2012 Apr;138(1-2):123-7. doi: 10.1016/j.jad.2011.12.003. Epub 2012 Jan 25. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D016574 | Seasonal Affective Disorder |
| D001523 | Mental Disorders |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| Red light placebo | Device | One hour of exposure to red light. |
|
|
| Measured weekly for 6 weeks |
| Food craving questionnaire | Measured daily for 6 weeks |
| Side effects questionnaire | Measured weekly for 6 weeks |
| Adherence questionnaire | Measured weekly for 6 weeks |
| Profile of Mood States | Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks |
| Beck Depression Inventory-II (BDI) | Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks |
| 22210362 | Background | Reeves GM, Nijjar GV, Langenberg P, Johnson MA, Khabazghazvini B, Sleemi A, Vaswani D, Lapidus M, Manalai P, Tariq M, Acharya M, Cabassa J, Snitker S, Postolache TT. Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder. J Nerv Ment Dis. 2012 Jan;200(1):51-5. doi: 10.1097/NMD.0b013e31823e56ca. |
| 20686638 | Background | Virk G, Reeves G, Rosenthal NE, Sher L, Postolache TT. Short exposure to light treatment improves depression scores in patients with seasonal affective disorder: A brief report. Int J Disabil Hum Dev. 2009 Jul;8(3):283-286. doi: 10.1901/jaba.2009.8-283. |
| D000068105 |
| Bipolar and Related Disorders |