2025-523549-92-00RecruitingPhase 4
The M-bipolar RCT
Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Jan 2026
Brief summary (registry, in English)
To conduct a 6-month RCT comparing effects of melatonin versus placebo on mood stabilisation and other critical patient outcomes in patients with bipolar disorder and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypotheses: Add on melatonin improves mood stabilization compared with add on placebo.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 24 Oct 2025
- Start date
- 16 Apr 2026
- Lead sponsor
- Region Hovedstaden
- Diseases
- Bipolar disorder
- EU CT number
- 2025-523549-92-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other
- Past intolerance to melatonin
- Impaired renal or hepatic function
- 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
- Speaks and writes danish or english at a level equal to mothers tongue
- Habile (i.e., able to give informed consent)
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Hovedstaden | Copenhagen Nv | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.