Melatonin Versus Placebo for Bipolar Disorder
Recruiting
Phase 2
Interventional Study
Bipolar Affective Disorder
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Lars Vedel Kessing · Other
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 …
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