Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

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.