drugset
drugset / Trial / NCT00076115

Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents

NCT00076115 ↗

Phase 3 Completed 13 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
RandomizedParallel-groupDouble-blindTreatment

Summary

A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.

Timeline

Start
2003-12
Primary completion
—
Completion
2005-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 0.5 mg Oral
Subject Risperidone Other / unclassified 2.5 mg Oral
Subject Risperidone Other / unclassified 3 mg Oral
Subject Risperidone Other / unclassified 6 mg Oral

Indications

bipolar I disorder