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Melatonin Versus Placebo for Bipolar Disorder

NCT07472075 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-12

No results posted yet for this study

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

Conditions

  • Bipolar Affective Disorder

Interventions

DRUG

Melatonin

Oral: Melatonin capsule 6 mg, 1 capsule/day

DRUG

Placebo

Oral Placebo capsule, 1 capsule/day

Sponsors & Collaborators

  • Lars Vedel Kessing

    lead OTHER

Principal Investigators

  • Lars Kessing · University hospital Bispebjerg and Frederiksberg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07472075 on ClinicalTrials.gov