Efficacy of melatonin as an adjunct in the treatment of acute mania
Phase 2
Recruiting
- Conditions
- Bipolar Disorder.Mania episode
- Registration Number
- IRCT201705181556N98
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
meeting the DSM-5 criteria for Bipolar Disorder; age between 18 and 65 years; a score of at least 20 points on the Young Mania Rating Scale.
Exclusion criteria: hyper- or hypothyroidism; substance dependence(except for Nicotine and caffeine); IQ lower than 70; history of allergy to lithium, risperidone and melatonin; lactating or pregnant women; receiving medications causing manic like symptoms including stimulants; cardiac conducting disturbance; serious risk of suicide.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of mania. Timepoint: Baseline and weerks 1, 2, 4, 6. Method of measurement: by Young Mania Rating Scale.
- Secondary Outcome Measures
Name Time Method Severity of extrapyramidal side effects. Timepoint: Baseline and weerks 1, 2, 4, 6. Method of measurement: By Extrapyramidal Symptom Rating Scale(ESRS).