Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

• stable with respect to disease symptoms and other medical conditions

• stable on antipsychotic therapy with oral risperidone 2 to 6 milligrams per day for 8 weeks before study

• if female, using birth control.

Exclusion Criteria:

• Hospitalized within 8 weeks of beginning the study

• at risk to self or others

• presence of liver or kidney damage

• use of oral antipsychotic drugs other than risperidone within the past 8 weeks, of injected antipsychotics within the past 6 months, of long-acting risperidone in an earlier study, of investigational drugs within the past 30 days, or of electroconvulsive therapy within the past 12 months

• pregnant or breast-feeding

• if female, not using birth control

• abusing drugs or alcohol.