NCT07472075RecruitingPhase 2
Melatonin Versus Placebo for Bipolar Disorder
Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 1 Mar 2026
- Start date
- 8 May 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Lars Vedel Kessing
- Diseases
- Bipolar disorder
- NCT number
- NCT07472075
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 8 May 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Past intolerance to melatonin (allergic reactions)
Lab values
- Impaired renal or hepatic function (defined by GFR \<60 ml/min and/or ALAT over allowed reference value)
Other
- Women who are pregnant, breastfeeding or planning pregnancy in near future.
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC) Coordinator of this site? Confirm its status | Frederiksberg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.