Effect of Melatonin on the components of metabolic syndrome in adolescent bipolarpatients taking risperidone plus lithium carbonate
Phase 2
- Conditions
- Bipolar disorder.Bipolar affective disorder
- Registration Number
- IRCT201208071556N44
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1-Bipolar Disorder type 1( according to DSM-IV criteria) 2-age between 11-17 3- weight within normal range
Exclusion criteria:
1-Active medical disease including seizure, hepatic disease, organic brain syndromes, Diabetes 2-history of metabolic syndrome 3-using appetizers such as antihistamines or appetite suppressors like amphetamines 4-heavy consumption of Xantine drivatives( tea, coffee and cacao)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body Mass Index. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Calculated as body weight (kg) divided by the height in meters squared.;High-density lipoprotein (HDL). Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Low- density lipoprotein. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Fasting blood sugar. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;TG. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Biochemistry.;Blood pressure. Timepoint: Baseline and weeks 6-12 after beginig of treatment. Method of measurement: Mercury sphygmomanometer.
- Secondary Outcome Measures
Name Time Method Severity of depression. Timepoint: Baseline and weeks 6 and 12 after startin treatment. Method of measurement: By Hamilton depression rating scale.;Severity of mania. Timepoint: Baseline and weeks 6 and 12 after startin treatment. Method of measurement: By Young mania rating scale.