Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
NCT ID: NCT06226025
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-08-13
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Melatonin
Oral medication will be taken for 28 days on the afternoon or evening of the participants first intervention session and continue daily for the remainder of the treatment period.
Melatonin
Participants randomized to this intervention will take 1 oral pill (0.5 milligrams (mg)) daily. They will attend 4 weekly behavioral sleep intervention sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.
Behavioral sleep intervention
An active intervention that is typically paired with melatonin to maximize treatment effects.
Placebo
Oral medication will be taken for 28 days on the afternoon or evening of the participants first intervention session and continue daily for the remainder of the treatment period.
Placebo
Participants randomized to this intervention will take 1 oral placebo pill daily. They will attend 4 weekly behavioral sleep control sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.
Behavioral sleep control
A behavioral placebo (which does not improve sleep in delayed sleep-wake phase disorder) to control for social/interpersonal effects of behavioral sleep intervention sessions.
Interventions
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Melatonin
Participants randomized to this intervention will take 1 oral pill (0.5 milligrams (mg)) daily. They will attend 4 weekly behavioral sleep intervention sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.
Placebo
Participants randomized to this intervention will take 1 oral placebo pill daily. They will attend 4 weekly behavioral sleep control sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.
Behavioral sleep intervention
An active intervention that is typically paired with melatonin to maximize treatment effects.
Behavioral sleep control
A behavioral placebo (which does not improve sleep in delayed sleep-wake phase disorder) to control for social/interpersonal effects of behavioral sleep intervention sessions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Natrol
UNKNOWN
National Institute of Mental Health (NIMH)
NIH
Leslie Swanson
OTHER
Responsible Party
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Leslie Swanson
Associate Professor of Psychiatry
Principal Investigators
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Leslie Swanson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00235778
Identifier Type: -
Identifier Source: org_study_id
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