Tests melatonin as an add-on treatment for bipolar disorder
Compares melatonin with a placebo in adults with bipolar disorder.
Key facts
- Who runs it
- Region Hovedstaden
- Where
- Copenhagen Nv, DenmarkSee the site
- Trial code
- Registry title
- The M-bipolar RCT
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 200 people, planned
- Started
- 16 Apr 2026
- Expected to end
- 30 Nov 2028
- Type of study
- Interventional
- Record updated
- 16 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with bipolar disorder. It compares melatonin with placebo for 6 months to see if melatonin helps keep mood stable.
- Age
- 18-70 years in the criteria; the registry age field lists 18 to 64 years.
- Sex
- All sexes can join.
- Disease stage
- Bipolar disorder, with the diagnosis confirmed by a SCAN interview.
Main reasons for not taking part
- Past intolerance to melatonin
- Impaired kidney or liver function
- Pregnant, breastfeeding or planning pregnancy in the near future
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Past intolerance to melatonin
- Impaired renal or hepatic function
- Women who are pregnant, breastfeeding or planning pregnancy in near future
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Denmark
- Region HovedstadenCopenhagen Nv, DenmarkTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)
- Plain-language title
- Tests melatonin as an add-on treatment for bipolar disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Fit questions
- Built from 2025-523549-92-00, who can take part
- Record updated
- 16 January 2026