drugset / Trial / NCT00182013

Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

NCT00182013

Phase 4 Completed 106 enrolled Massachusetts General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2001-06
Primary completion
2004-02
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule
Subject Quetiapine Small molecule 175.8 mg
Subject Quetiapine Small molecule 248.7 mg
Subject Risperidone Other / unclassified

Indications