drugset / Trial / NCT07472075

Melatonin Versus Placebo for Bipolar Disorder

NCT07472075

Phase 2 Recruiting 200 enrolled Lars Vedel Kessing
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2026-05-08
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 6 mg Oral

Indications