drugset / Trial / NCT00216476

A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder

NCT00216476

Phase 3 Completed 753 enrolled Janssen-Cilag International NV
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.

Timeline

Start
2004-10
Primary completion
2007-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 10 mg Oral
Subject Aripiprazole Other / unclassified 30 mg Oral
Comparator Quetiapine Small molecule 300 mg Oral
Comparator Quetiapine Small molecule 400 mg Oral
Subject Risperidone Other / unclassified 25 mg Intramuscular

Indications