Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

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

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: National Institute of Mental Health (NIMH); Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Clozapine; Risperidone

Criteria

Inclusion Criteria:

• DSM-IV criteria for schizophrenia or schizoaffective disorder

• Current clozapine treatment

• Moderate illness severity and inadequate positive symptom response to clozapine treatment

• 6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

Exclusion Criteria:

• Organic brain disorder

• Mental retardation

• Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol

• Pregnancy

• DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month

• Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks