A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.

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

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Janssen, LP
• Treatments: Antipsychotic Agents; Risperidone

Criteria

Inclusion Criteria:

• Patients diagnosed with schizophrenia or schizoaffective disorder

• stable with respect to disease symptoms and other medical conditions

• stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study

• patients identify a relative or acquaintance who can complete a questionnaire with additional information about the patient

• if female, using birth control.

Exclusion Criteria:

• Patient is not eligible if currently hospitalized, or was treated for an acute disease-related crisis within the past 4 weeks

• at risk to self or others

• use of injectable antipsychotic drugs or electroconvulsive therapy within past 6 months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months

• presence of liver or kidney damage

• history of neuroleptic malignant syndrome

• if pregnant or breast-feeding

• not using birth control

• abusing drugs or alcohol.