Actively Recruiting
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Led by Leslie Swanson · Updated on 2026-05-11
50
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
L
Leslie Swanson
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Diagnosed with bipolar disorder type I or II according to DSM criteria
- Evening chronotype with Morningness-Eveningness Questionnaire (MEQ) score below 42
- At least mild depressive symptoms with Patient Health Questionnaire (PHQ)-9 score of 5 or higher
- Psychotropic medications at stable dose for at least the past month
- Able to download and use the MyDataHelps mobile app on their own phone
- Willing to abstain from alcohol during the intervention phase
- Female participants of childbearing potential must agree to use reliable contraception from screening until 4 weeks after study completion
You will not qualify if you...
- Current diagnosis or high risk of sleep disorders other than delayed sleep-wake phase disorder, including insomnia, sleep-disordered breathing, restless leg syndrome, narcolepsy, or vasomotor symptoms affecting sleep
- Risk of current mania with Young Mania Rating Scale (YMRS) score over 19
- Suicidal or high risk for suicide per Columbia Suicide Severity Rating Scale (C-SSRS) guidelines or investigator judgment
- Presence of cardiac implantable electronic devices like defibrillators or pacemakers
- Chronic psychiatric conditions influencing sleep, including current illicit drug use, current alcohol or drug abuse, or current psychosis
- Unstable chronic medical conditions affecting sleep such as chronic pain or thyroid issues
- Medical conditions affected by melatonin including hypertension, hypotension, diabetes, clotting or bleeding disorders, epilepsy, autoimmune disorders, or need for immunosuppressive management
- Current use of medications that interact with melatonin or interfere with its measurement
- Use of melatonin within the past month
- Hypersensitivity to melatonin or any product components
- Pregnancy, breastfeeding, or plans to become pregnant within 3 months
- Routine night shift work
- Travel across multiple time zones in the past month or planned during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
K
Kelley DuBuc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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