Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 60

Using melatonin to improve mood and sleep in bipolar disorder

Official title: Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Run by University of Michigan · NCT06226025 · Data updated 2026-11-12

This study is testing if a low dose of melatonin, along with a sleep program, can help improve mood and sleep for people with bipolar disorder.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment50 (estimated)
SponsorUniversity of Michigan
Academic / other
Locations1 site (Ann Arbor, Michigan)
StatusRecruiting
StartedAugust 13, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedMay 11, 2026
Trial IDNCT06226025 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with bipolar disorder who have an evening chronotype and mild depressive symptoms.

Probably not a fit

Patients with bipolar disorder who do not have evening chronotype or are not experiencing depressive symptoms may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests the effectiveness of low-dose melatonin combined with a behavioral sleep intervention to shift the brain's circadian clock earlier in individuals with bipolar disorder. Participants will be randomly assigned to receive either melatonin with the behavioral intervention or a placebo with a behavioral sleep placebo. The study aims to measure changes in sleep patterns and mood, specifically looking at the dim light melatonin onset and depressive symptoms. An open-label phase will allow previous placebo participants to receive the active treatment after completing the initial trial.

Why it matters

Potential benefit: If successful, this approach could significantly improve mood and sleep quality for patients with bipolar disorder.

How similar studies have gone: Previous studies have shown promise in using melatonin for circadian rhythm disorders, but this specific combination approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting

Study contacts

  • Principal investigator: Leslie Swanson, PhD — University of Michigan
  • Study coordinator: Kelley DuBuc
  • Email: dubuck@umich.edu
  • Phone: 734-764-2256

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.