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Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
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.
Details
| Lead sponsor | Leslie Swanson |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 50 |
| Start date | 2024-08-13 |
| Completion | 2026-12 |
Conditions
- Bipolar Disorder
- Delayed Sleep-Wake Phase Disorder
Interventions
- Melatonin
- Placebo
- Behavioral sleep intervention
- Behavioral sleep control
Primary outcomes
- Change in time of Dim Light Melatonin Onset (DLMO) baseline (pre-treatment) to 4 weeks (post-treatment) — 4 weeks (after treatment period)
Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.
Countries
United States