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NOT YET RECRUITING
NCT07472075
PHASE2

Melatonin Versus Placebo for Bipolar Disorder

Sponsor: Lars Vedel Kessing

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

Official title: Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-03

Completion Date

2028-06

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

Melatonin

Oral: Melatonin capsule 6 mg, 1 capsule/day

DRUG

Placebo

Oral Placebo capsule, 1 capsule/day

Locations (1)

Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)

Frederiksberg, Denmark