Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .

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

Details

• Lead Sponsor: Janssen Pharmaceutica N.V., Belgium
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV)

• acute episode of schizophrenia within 2 weeks of study entry

• o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose

• Positive And Negative Syndrome Scale (PANSS) score >=80

• Clinical Global Impression - Severity (CGI-S) score >=5

Exclusion Criteria:

• DSM-IV axis I diagnosis other than schizophrenia

• known hypersensitivity or lack of response to risperidone

• pregnant or nursing females, or those without adequate contraception

• alcohol or drug abuse or dependence diagnosed in the last month prior to entry,