The M-bipolar RCT
Key facts
- Where
- Copenhagen Nv, DániaSee the site
- Phase
- 4. fázis
Could this be for you?
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 Dánia
- Region HovedstadenCopenhagen Nv, DániaTaking people
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?
Trial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2025-523549-92-00
- Record updated
- 2026. január 16.
- Original description
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.Read full original descriptionShow less
Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)
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.
Inclusion: 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).
Exclusion: Past intolerance to melatonin; Impaired renal or hepatic function; Women who are pregnant, breastfeeding or planning pregnancy in near future.