A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).

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

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• In-patients or out-patients

• Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness

• Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2

• Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive

• Able to complete self-assessments in either English or French

Exclusion Criteria:

• Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to DSM-IV

• Current drug or alcohol dependence

• Treatment with a depot antipsychotic within 3 months of study start

• Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone

• Risperidone non-responders (based on evidence of adequate trial of treatment)