Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Ten Participants that competed the randomized trial and were assigned to the placebo group (and meet eligibility) can participate in the open label part of this project. Participants will sign a separate consent for this open label part. ;

Study Design

Related Conditions & MeSH terms

Bipolar Disorder
Delayed Sleep-Wake Phase Disorder

Clinical Trial Details

NCT number	NCT06226025
Study type	Interventional
Source	University of Michigan
Contact	Kelley DuBuc
Phone	734-764-2256
Email	dubuck@umich.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	May 2024
Completion date	April 2026

View Details

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