drugset / Trial / NCT00246246

A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder

NCT00246246

Phase 3 Completed 48 enrolled Janssen-Ortho Inc., Canada
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and effectiveness of a long-acting injectable formulation of risperidone in stable bipolar patients randomly switched from their current add-on oral antipsychotic (olanzapine, risperidone, or quetiapine) therapy to long-acting injectable risperidone. The patients switched to long-acting injectable risperidone will be compared to patients who continue on their oral antipsychotic treatment regimen

Timeline

Start
2004-01
Primary completion
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 25 mg Intramuscular

Indications