RECRUITING

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Conditions

Bipolar Disorder Delayed Sleep-Wake Phase Disorder Correcting Circadian Rhythms Melatonin Placebo Dim light melatonin onset

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Quick Facts

Study Start:2024-08-13

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06226025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Capable of giving informed consent * Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for Bipolar disorder (BD) I or II * International Classification of Sleep Disorders (ICSD)-3 diagnosis of Delayed sleep phase disorder (DSPD): (1) have evidence of a delayed phase of the sleep-wake pattern on daily sleep diaries and actigraphy maintained for at least 7 days (e.g., a greater or equal to a 2 hour delay in the timing of habitual sleep episode between work/school and free days); (2) report difficulty falling asleep and difficulty awakening at desired/required times for ≥ 3 months. * 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.	* 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 * Current alcohol or drug abuse * 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.

Inclusion Criteria

Exclusion Criteria

* Capable of giving informed consent
* Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for Bipolar disorder (BD) I or II
* International Classification of Sleep Disorders (ICSD)-3 diagnosis of Delayed sleep phase disorder (DSPD): (1) have evidence of a delayed phase of the sleep-wake pattern on daily sleep diaries and actigraphy maintained for at least 7 days (e.g., a greater or equal to a 2 hour delay in the timing of habitual sleep episode between work/school and free days); (2) report difficulty falling asleep and difficulty awakening at desired/required times for ≥ 3 months.
* 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.

* 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
* Current alcohol or drug abuse
* 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.

Contacts and Locations

Study Contact

Kelley DuBuc

CONTACT

734-764-2256

dubuck@umich.edu

Principal Investigator

Leslie Swanson, PhD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: Leslie Swanson

Leslie Swanson, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-08-13

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Correcting Circadian Rhythms
Melatonin
Placebo
Dim light melatonin onset

Additional Relevant MeSH Terms

Bipolar Disorder
Delayed Sleep-Wake Phase Disorder