Phase 2 Bipolar Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are able to understand and agree to take part in the study on your own.
• You have been diagnosed with Bipolar Disorder I or II.
• You tend to feel most alert and active in the evening rather than the morning (based on a specific questionnaire score).
• You are experiencing at least mild symptoms of depression (based on a specific questionnaire score).
• Any mental health medications you take have been at the same dose for the past month.
• You are able to download and use the MyDataHelps app on your own smartphone.
• You are willing to avoid alcohol for the duration of the treatment part of the study.
• If you are a woman who could become pregnant, you agree to use a reliable form of birth control from the start of the study until 4 weeks after it ends.

Who may not be able to join:

• You have, or are at high risk for, a sleep disorder other than a condition called Delayed Sleep Phase Disorder — this includes insomnia, sleep apnea, restless leg syndrome, or narcolepsy (confirm with trial site).
• You are a woman who may be going through perimenopause or menopause and hot flashes or night sweats are affecting your sleep.
• You are currently showing signs of a manic episode based on a rating scale used by the study team.
• You are currently having thoughts of suicide or have made a suicide attempt or related actions in the past 3 months.
• You have a cardiac device implanted in your body, such as a pacemaker or defibrillator.
• You are currently using illicit drugs at a level considered significant based on a screening questionnaire.
• You are currently misusing alcohol or drugs at a level considered significant based on a screening questionnaire.
• You are currently experiencing psychosis (a break from reality, such as hearing or seeing things others do not).
• You have an unstable long-term medical condition that affects your sleep, such as chronic pain or a thyroid condition.
• You have, or have had, certain medical conditions that may be affected by melatonin, including high or low blood pressure, diabetes (Type 1 or 2), clotting or bleeding disorders, epilepsy or seizures, autoimmune disorders, or conditions requiring medications that suppress the immune system (such as after a transplant).
• You currently take medications that may interact with melatonin (confirm with trial site for the specific list).
• You currently take daily anti-inflammatory pain medications (like ibuprofen) or beta-blocker medications, as these can interfere with measuring melatonin levels.
• You have used melatonin supplements in the past month.
• You are allergic or sensitive to melatonin or any ingredient in the melatonin or placebo product used in the study.
• You are currently pregnant, breastfeeding, or planning to become pregnant in the next 3 months.
• You regularly work night shifts.
• You have travelled across more than one time zone in the past month, or plan to do so during the study.

Important: Always verify eligibility with the trial site directly before applying.