Effect of melatonin versus placebo on the sleep improvement and quality of life in patients with bipolar disorder in the manic phase
Phase 2
- Conditions
- Bipolar disorder.Bipolar disorder
- Registration Number
- IRCT20120215009014N314
- Lead Sponsor
- Hamedan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Age of 18 to 65 years,
Bipolar disorder in manic phase
Exclusion Criteria
Panic disorder or social phobia,
Depressive disorder,
Schizophrenia,
Alcohol or drug abuse,
History of suicide in the past year
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of sleep. Timepoint: Before the intervention and 4 weeks after that. Method of measurement: By Insomnia Severity Index (ISI).;Quality of life. Timepoint: Before the intervention and 4 weeks after that. Method of measurement: By Young Mania Rating Scale (YMRS).
- Secondary Outcome Measures
Name Time Method