Melatonin versus placebo for bipolar disorder - a double blinded randomised controlled trial (The M-bipolar RCT)
Phase 4 – monitoring after market approval
Conditions:
Bipolar disorder
Sponsor: Region Hovedstaden
trial.available_in:
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Overview
Trial status: Authorised
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
Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system
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
Who can participate
Age group: 18-64 years
Gender: Female, Male
Target enrollment: 200 participants
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