drugset / Trial / NCT00181935

Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder

NCT00181935

Phase 4 Completed 40 enrolled Massachusetts General Hospital
Non-randomizedParallel-groupSingle-blindTreatment

Summary

The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of extrapyramidal side effects.

Timeline

Start
2001-03
Primary completion
Completion
2004-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule
Subject Risperidone Other / unclassified