RecruitingPhase 2NCT07472075

Melatonin Versus Placebo for Bipolar Disorder

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


Sponsor

Lars Vedel Kessing

Enrollment

200 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Melatonin and a drug called Placebo for people with bipolar affective disorder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelatonin

Oral: Melatonin capsule 6 mg, 1 capsule/day

DRUGPlacebo

Oral Placebo capsule, 1 capsule/day


Locations(1)

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

Frederiksberg, Denmark

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NCT07472075


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