Melatonin Compared With Placebo for People With Bipolar Disorder
Tests melatonin added to usual care in adults with bipolar disorder.
Plain-language title generated from the registry record
Registry title: Melatonin Versus Placebo for Bipolar Disorder
Key facts
- Where
- Frederiksberg, DenmarkSee the site
- Phase
- Phase 2
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 70 years old?
Source: NCT07472075, who can take part
Where in Denmark
- Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)Frederiksberg, DenmarkTaking 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
- Lars Vedel Kessing
- Trial code
- NCT07472075
- Record updated
- 12 May 2026
- Original description
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 relapseRead full original descriptionShow less
Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
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
Inclusion: 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: 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.