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Melatonin and Behavioral Therapy for Bipolar Disorder and Sleep Issues

This study is testing if a low dose of melatonin, a dietary supplement, combined with behavioral sleep therapy can help people with bipolar disorder who also have delayed sleep-wake phase disorder (often called being a "night owl"). Researchers want to see if this combination can shift your body's internal clock earlier and improve your mood and sleep. You would either receive melatonin plus behavioral sleep intervention, or a placebo (an inactive pill) plus a control behavioral sleep session. To join, you need to be 18-60 years old, have bipolar disorder (Type I or II), be an "evening person," and have at least mild depressive symptoms. The study aims to see if the melatonin and behavioral intervention group shows a greater shift in their sleep-wake cycle compared to the placebo group.

Study design
This is an interventional study planning to enroll 50 participants. You would be randomly assigned to one of two groups: melatonin plus behavioral sleep intervention, or placebo plus a behavioral sleep control.
What's involved
You would take one pill daily and attend 4 weekly behavioral sleep sessions with a therapist. You would also complete questionnaires, monitor your sleep, collect saliva samples, and wear a Fitbit device.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 4 weeks after the treatment period.

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NCT06226025

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Recruiting
PHASE2Ages 18–60InterventionalTreatment
Leslie Swanson
~50 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:MelatoninPlaceboBehavioral sleep interventionBehavioral sleep control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in time of Dim Light Melatonin Onset (DLMO) baseline (pre-treatment) to 4 weeks (post-treatment)
Measured over 4 weeks (after treatment period)

Conditions

Bipolar Disorder
Delayed Sleep-Wake Phase Disorder

Explore related trials

Bipolar DisorderDelayed Sleep Phase Type Circadian Rhythm Sleep Disorder

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Leslie Swanson, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Kelley DuBuc
[email protected]
734-764-2256
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in time of Dim Light Melatonin Onset (DLMO) baseline (pre-treatment) to 4 weeks (post-treatment)4 weeks (after treatment period)

    Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.