Clinical Trial

Melatonin Versus Placebo for Bipolar Disorder

Study acronym: M-bipolar RCT
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-05
Trial Details
NCT Number NCT07472075
Lead Sponsor Lars Vedel Kessing
Conditions Bipolar Affective Disorder
Enrollment 200 participants
Start Date 2026-05-08
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-12