NCT06226025 Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
| NCT ID | NCT06226025 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Leslie Swanson |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2026-04 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Capable of giving informed consent * Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for bipolar disorder (BD) I or II * Evening chronotype per the Morningness-Eveningness Questionnaire (MEQ) defined by a score of \<42 * At least mild depressive symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5 * Psychotropic medications at stable dose for past month * Able to download the MyDataHelps mobile application (app), and open app on participants' own phone * Willing to abstain from alcohol for the duration of the intervention phase * Female participants of childbearing potential (i.e., patients are not permanently sterilized (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or postmenopausal (12 months with no menses without an alternative medical cause) by report) must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed. Exclusion Cri
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