CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia

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

Summary

This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to be used in the study, clozapine and risperidone, are fully approved for the treatment of schizophrenia.

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

Details

• Lead Sponsor: University of British Columbia
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Subjects treated with clozapine for the indication of poor response to other antipsychotic medications.

• Treatment with clozapine is at a stable dose for at least 12 weeks. Dose must be 400 mg/day or more, unless side effects limited increase of dose.

Exclusion Criteria:

• Subjects with significant alcohol or substance abuse in the past 3 months.

• Subjects with a previous trial of risperidone augmentation of clozapine

• Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception

• Subjects requiring treatment with anticonvulsants.

• Subjects with known hypersensitivity or allergy to risperidone.

• Subjects with hematological or other contraindications to continued clozapine treatment.