Melatonin Versus Placebo for Bipolar Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Placebo.
- Who it may be relevant to
- Registry conditions: Bipolar Affective Disorder. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
Overview
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
Detailed description
Sleep abnormalities are common in all phases of bipolar disorder (BD) and constitute core symptoms of both depression and mania also during remitted phases and despite treatment.
Melatonin is a key circadian hormone, that expresses a robust circadian rhythm and acts as an important endogenous modulator of the circadian timing system of sleep and may thus improve sleep and stabilize BD per se. Nevertheless, sleep in general and melatonin specifically is critically understudied in BD reflecting a central key knowledge gap within psychiatry. The investigators want in a 6-month randomized placebo-controlled trial (RCT) to compare effects of add on melatonin versus add on placebo on mood stabilisation and other critical patient outcomes in patients with BD.
Interventions
- Drug Melatonin
Oral: Melatonin capsule 6 mg, 1 capsule/day - Drug Placebo
Oral Placebo capsule, 1 capsule/day
Primary outcome measures
- Mood stabilization [Time frame: 6 months]
Secondary outcome measures (2)
- Sleep [Time frame: 6 months]
- Depression [Time frame: Changes between baseline, 3 months and 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC) — Frederiksberg
Identifiers
NCT: NCT07472075 · EUCT2025-523549-92-00 · Grant ID: 10.46540/00004B