Melatonin Versus Placebo for Bipolar Disorder
Recruiting · NCT07472075 · Interventional (participants receive a specific treatment) · Lead sponsor: Lars Vedel Kessing
View the official record on ClinicalTrials.gov →Interventions studied
MelatoninPlacebo
What this trial is about
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
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC) - Frederiksberg, Denmark