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
| Condition(s) | Bipolar Disorder, Delayed Sleep-Wake Phase Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | Leslie Swanson |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2024-08-13 |
| NCT ID | NCT06226025 |
| Official listing | https://clinicaltrials.gov/study/NCT06226025 |