Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder (NCT06226025)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: University of Michigan — Ann Arbor, Michigan
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Michigan — Ann Arbor, Michigan
📞 Contact the Study Coordinator
Phone: (734) 764-2256
Email: dubuck@umich.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bipolar Disorder
- Early Intervention for Youth at High Risk for Bipolar Disorder — Pittsburgh, Pennsylvania
- Evaluation of the Genetics of Bipolar Disorder — Bethesda, Maryland
- Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth — Toronto, Ontario
- Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression — Belmont, Massachusetts
- Characterizing MyMood Patterns of Use — Toronto, Ontario
- A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder — Boston, Massachusetts
Explore by condition: All Bipolar Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.