drugset / Trial / NCT00992407

An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder

NCT00992407

Phase 4 Completed 75 enrolled Janssen Korea, Ltd., Korea
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder).

Timeline

Start
2007-12
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Risperidone Other / unclassified 0.5 mg Intramuscular
Subject Risperidone Other / unclassified 10 mg Intramuscular
Subject Risperidone Other / unclassified 25 mg Intramuscular
Subject Risperidone Other / unclassified 37.5 mg Intramuscular
Subject Risperidone Other / unclassified 50 mg Intramuscular

Indications