Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics 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-Cilag Ltd.
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

• Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months

• Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months

• Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4

• Be not pregnant as showed on negative pregnancy serum test

Exclusion Criteria:

• Contraindication or known hypersensitivity to risperidone

• Previous history of unsatisfactory response to risperidone

• Previous history of refractivity to the other second generation antipsychotics

• Use of antipsychotic of intramuscular deposit in the last 12 months

• Other mental disturbances of DSM-IV axis