RecruitingPhase 2

Melatonin Versus Placebo for Bipolar Disorder

Denmark200 participantsStarted 2026-05

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Mood stabilization

Timeframe: 6 months

Trial details

NCT IDNCT07472075

SponsorLars Vedel Kessing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Lars Kessing

+45 38647081 lars.vedel.kessing@regionh.dk

View on ClinicalTrials.gov More Bipolar Affective Disorder trials