Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder
The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.
Bipolar Spectrum Disorder
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Young Mania Rating Scale [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]Improvement defined as score reduction of 30% or greater.
|Study Start Date:||June 2001|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182013
|Principal Investigator:||Joseph Biederman, MD||MGH|