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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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)
Exclusion Criteria:
* Past intolerance to melatonin (allergic reactions)
* Impaired renal or hepatic function (defined by GFR \<60 ml/min and/or ALAT over allowed reference value)
* Women who are pregnant, breastfeeding or planning pregnancy in near future.
Primary outcome measure(s)
Mood stabilization — 6 months Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings.
Trial sites (1)
Facility
City
Region
Status
Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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