Study design & results
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Trial intelligence / Profile preview
M-bipolar RCT
2025-523549-92-00Phase 4Authorised
- Sponsor
- Capital Region of Denmark
- Start
- Jan 2026
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 4, randomised, double-blind trial in bipolar disorder (BD) comparing Melatonin (Orimelan) with Placebo (2 arms). Primary endpoint: Mood stabilization. Planned start Jan 2026; status: authorised.
02
Drugs
melatonin
03
Conditions
bipolar disorder (BD)
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Study design, results and competitive context are available in the Gosset platform where reported.
Competitive context
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