Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Denmark
Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)
RECRUITING
Frederiksberg
Contact Information
Primary
Lars Kessing
lars.vedel.kessing@regionh.dk
+45 38647081
Time Frame
Start Date: 2026-05-08
Estimated Completion Date: 2028-06
Participants
Target number of participants: 200
Treatments
Active_comparator: Melatonin
100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded.
Placebo_comparator: Placebo
100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded.
Related Therapeutic Areas
Sponsors
Leads: Lars Vedel Kessing