An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)

• Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication

• Participants who have signed informed consent form Exclusion Criteria:

• Participants who have never received any previous antipsychotic treatment

• Participants who have received clozapine during the last 3 months

• Participants with a serious unstable medical condition, including laboratory abnormalities

• Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)

• Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception