Melatonin versus placebo for bipolar disorder
Official title: Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
Run by University Hospital Bispebjerg and Frederiksberg · NCT07472075 · Data updated 2026-11-12
This 6-month trial will try adding melatonin to usual treatment for adults with bipolar disorder to see if it improves sleep and mood stability.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Frederiksberg) |
| Status | Recruiting |
| Started | May 8, 2026 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07472075 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with bipolar disorder confirmed by a SCAN interview who can read English or Danish and give informed consent are the intended participants.
✕Probably not a fit
People who are pregnant or breastfeeding, have significant kidney or liver impairment, or have a past intolerance to melatonin are unlikely to benefit or be eligible for this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Sleep abnormalities are common across all phases of bipolar disorder and can contribute to both depressive and manic episodes. Melatonin is a circadian hormone that helps regulate sleep timing and may stabilize mood by supporting the circadian system. In this 6-month randomized, double-blind, placebo-controlled trial, adults will receive add-on melatonin or matching placebo alongside their usual treatment to compare effects on mood stability, sleep, relapse rates, and potential antimanic or antidepressant effects. Outcomes will be measured with standardized mood assessments and relapse monitoring.
Why it matters
Potential benefit: If successful, adding melatonin to standard treatment could improve sleep, reduce mood swings, and lower the risk of relapse for people with bipolar disorder.
How similar studies have gone: Melatonin has demonstrated benefits for sleep in other groups, but randomized trials testing it as an add-on treatment in bipolar disorder are limited, making this a relatively novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bipolar disorder with diagnosis confirmed by SCAN interview * Age 18 - 70 years * The participants must be able to read and understand the participant information in their native language and consent (English and Danish) * Habile (i.e able to give informed consent) Exclusion Criteria: * Past intolerance to melatonin (allergic reactions) * Impaired renal or hepatic function (defined by GFR \<60 ml/min and/or ALAT over allowed reference value) * Women who are pregnant, breastfeeding or planning pregnancy in near future.
Where it's running
-
Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)
Frederiksberg, Denmark Recruiting
Study contacts
- Principal investigator: Lars Kessing — University hospital Bispebjerg and Frederiksberg Hospital
- Study coordinator: Lars Kessing
- Email: lars.vedel.kessing@regionh.dk
- Phone: +45 38647081
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.