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

Bipolar Affective Disorder

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

Inclusion Criteria4

Bipolar disorder with diagnosis confirmed by SCAN interview
Age 18 - 70 years
The participants must be able to read and understand the participant information in their native language and consent (English and Danish)
Habile (i.e able to give informed consent)

Exclusion Criteria3

Past intolerance to melatonin (allergic reactions)
Impaired renal or hepatic function (defined by GFR <60 ml/min and/or ALAT over allowed reference value)
Women who are pregnant, breastfeeding or planning pregnancy in near future.

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