Status:
COMPLETED
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
Lead Sponsor:
University of British Columbia
Conditions:
Psychosis, Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Subjects may be inpatients or outpatients. All subjects will be treated throughout the study with clozapine, at a dose of 400 mg or more, unless limited by side effects. After screening, subjects will...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00272584
Start Date
June 1 2001
End Date
January 1 2004
Last Update
May 8 2006
Active Locations (1)
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1
UBC Hospital
Vancouver, British Columbia, Canada