Condition: Bipolar Disorder · Delayed Sleep-Wake Phase Disorder · Sponsor: Leslie Swanson
The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo. The hypotheses for this study include: * Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment. * Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.
This description comes directly from the study's public registry record.
Kelley DuBuc · 734-764-2256 · dubuck@umich.edu
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| University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06226025