Actively Recruiting
Melatonin Versus Placebo for Bipolar Disorder
Led by Lars Vedel Kessing · Updated on 2026-05-12
200
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Melatonin Versus Placebo for Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bipolar disorder diagnosis confirmed by SCAN interview
- Age between 18 and 70 years
- Able to read and understand participant information in English or Danish
- Able to give informed consent
You will not qualify if you...
- Past intolerance or allergic reaction to melatonin
- Impaired kidney or liver function (GFR <60 ml/min or elevated ALAT)
- Women who are pregnant, breastfeeding, or planning pregnancy in the near future
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)
Frederiksberg, Denmark, 2000
Actively Recruiting
Research Team
L
Lars Kessing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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