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New treatment option for Bipolar Disorder
Official title Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder
ClinicalTrials.gov ID: NCT06226025
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for bipolar disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.