The effect of quetiapine in children and adolescents with bipolar I disorder
Not Applicable
- Conditions
- Bipolar disorder type I, manic or mixed episode.Bipolar affective disorder, current episode manic without psychotic symptoms, Bipolar affective disorder, current episode manic with psychotic symptoms, Bipolar affective disorder, current episode mixedF31-1, F31
- Registration Number
- IRCT201205059645N1
- Lead Sponsor
- niversity of Social Welfare and Rehabilitation Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
ages 10-17 with bipolar I disorder, manic or mixed episode
Exclusion criteria: YMRS score < 20 ( young mania rating scale); mood symptoms secondary to substance intoxication or withdrawal; substance use disorders 3 months prior to study; mental retardation; severe medical diseases; serious neurologic disorders; autistic disorder; history of hypersensitivity or intolerance or nonresponse to quetiapine or risperidone or lithium; use of long acting antipsychotics 3 months prior to study; use of antidepressants or antipsychotics 1 week prior to study; use of psychostimulants or benzodiazepines 72 hours prior to study
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of manic or mixed episode. Timepoint: every two weeks. Method of measurement: Young Mania Rating Scale and Children's Depression Rating Scale.
- Secondary Outcome Measures
Name Time Method Psychotic symptoms. Timepoint: every two weeks. Method of measurement: positive and negative syndrome scale - positive subscale.;General improvement. Timepoint: every two weeks. Method of measurement: clinical global impression-Improvement.;General functioning. Timepoint: baseline and endpoint. Method of measurement: children's global assessment scale.;Extrapyramidal side effects. Timepoint: weeks 1,2,4,6. Method of measurement: simpson-angus extrapyramidal side effects scale, barnes akathisia scale, abnormal involuntary movement scale.;Other side effects. Timepoint: weeks 1, 2, 4, 6. Method of measurement: side effects checklist.