Can a night owl pill fix bipolar mood swings?
NCT ID NCT06226025
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a low-dose melatonin pill (0.5 mg) combined with a behavioral sleep program can shift the body's internal clock earlier and improve mood in people with bipolar disorder who are night owls. Fifty participants will either get melatonin plus sleep therapy or a placebo plus a control sleep session. The goal is to see if this approach reduces depressive symptoms and advances the timing of melatonin onset.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Melatonin (0.5 mg daily oral pill)
- What this could lead to
- If it works, this could point toward a simple, low-cost way to improve mood and sleep in people with bipolar disorder who are night owls.
- What could go wrong
- This is a small, early-phase trial with only 50 participants, so results may not apply widely. Melatonin is generally safe but may not shift sleep timing enough to help everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Criteria: * Current diagnosis of, or high risk for, a sleep disorder other than DSPD per interview and medical record review (when available) including: * Insomnia per DSM-5 * Sleep-disordered breathing per Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP-BANG) * Restless leg syndrome per sleep interview * Narcolepsy * Suspicion of vasomotor symptoms impacting sleep per interview for women that may be perimenopausal or postmenopausal. * Risk of current mania (per Young Mania Rating Scale (YMRS) score \> 19). * Suicidal or at high risk for suicide per Columbia Suicide Severity Rating Scale (C-SSRS) guidelines (i.e., presence of any suicidal behavior-suicide attempt, interrupted attempt, abort attempt, or preparatory behavior-in the past 3 months; and/or current active suicidal ideation with any intent), or as determined by the principal investigators. * Presence of cardiac implantable electronic device, such as defibrillator or pacemaker. * Presence of chronic psychiatric conditions which may directly influence sleep per interview and medical record review (when available), including: * Current illicit drug use per the Drug Use Disorders Identification Test (DUDIT) defined by a score of ≥ 25 * Current alcohol or drug abuse per the Alcohol Use Disorder Identification Test (AUDIT) defined by a score of ≥ 16 and DUDIT * Currently experiencing psychosis * Presence of unstable chronic medical condition which may directly influence sleep: * Chronic pain * Thyroid conditions * Current or history of medical conditions which may be affected by melatonin per self-report and medical record review (when available), such as: * Hypertension or hypotension * Diabetes Type 1 or Type 2 * Clotting/bleeding disorders * Epilepsy/seizures * Autoimmune disorders * Conditions requiring immunosuppressive management such as transplant * Per self-report or medical record review (when available), current use of medications which may have interactions with melatonin (see protocol for more details). * Current use of medications that may interfere with the measurement of melatonin (non-steroidal anti-inflammatory drugs if used daily, and beta-blockers), per self-report and medical record review (when available). * Self-report use of melatonin in the past month. * Hypersensitivity to melatonin or any other component of the melatonin or placebo product. * Pregnancy (as determined by dipstick urinary pregnancy test at screening for women of child-bearing potential) or self-report of breastfeeding and/or plan to become pregnant in the next 3 months. * Self-report of routine night shift work. * Self-report of past month travel or planned travel during the study across more than one time zone.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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