drugset / Trial / NCT00526877

An Efficacy and Safety Study of Long-acting Risperidone in Participants With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment

NCT00526877

Phase 4 Completed 31 enrolled Johnson & Johnson Taiwan Ltd
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) and schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), who are receiving psychiatric home-care treatment .

Timeline

Start
2007-07-13
Primary completion
2009-01-31
Completion
2009-01-31

Drugs

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