Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT07472075

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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