Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523549-92-00

Enrollment

200

Registered

2026-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder

Brief summary

Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system

Detailed description

Hamilton D6, Pittsburgh Sleep Quality, Young Mania Rating Scale, Functioning Assessment Short Test (FAST), internet-based Cognition Assessment Tool (ICAT) and bloodbased inflammation markers in bloodsamples, hair cortisol and urine oxidative stress markers

Interventions

DRUGPLACEBO

DRUGOrimelan 3 mg tabletter

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system	—

Secondary

Measure	Time frame
Hamilton D6, Pittsburgh Sleep Quality, Young Mania Rating Scale, Functioning Assessment Short Test (FAST), internet-based Cognition Assessment Tool (ICAT) and bloodbased inflammation markers in bloodsamples, hair cortisol and urine oxidative stress markers	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026