NCT00272584|CompletedPhase 4
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
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International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Sponsor study identifier
interventional
100
1 country
1
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
January 3, 2006
Actual (reported)January 6, 2006
Actual (reported)For 100 subjects with incomplete response to adequate treatment with clozapine, the primary objective is to determine if risperidone augmentation of clozapine is superior to augmentation with placebo, using the outcome measure of total PANSS score
Additional outcome measures will be: proportion of subjects with a 20% or greater reduction in PANSS total score, CGI severity score, CGI improvement score and SOFAS score.
To assess the safety of risperidone augmentation, severity of extrapyramidal side effects, metabolic measures, and general side effects will be studied. Hematological monitoring will be carried out.
To determine if risperidone augmentation has effects on cognition, a neuropsychological test battery will be carried out.
The predictive value of neurocognitive testing, and DNA analysis for results of risperidone augmentation will be studied.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UBC Hospital
Vancouver, British Columbia, Canada
Honer WG, Thornton AE, Chen EY, Chan RC, Wong JO, Bergmann A, Falkai P, Pomarol-Clotet E, McKenna PJ, Stip E, Williams R, MacEwan GW, Wasan K, Procyshyn R; Clozapine and Risperidone Enhancement (CARE) Study Group. Clozapine alone versus clozapine and risperidone with refractory schizophrenia. N Engl J Med. 2006 Feb 2;354(5):472-82. doi: 10.1056/NEJMoa053222.
Thornton AE, Procyshyn RM, Barr AM, MacEwan GW, Honer WG. Cognition and Plasma Ratio of Clozapine to N-desmethylclozapine in Patients With Clozapine-Resistant Schizophrenia. Am J Psychiatry. 2015 Dec;172(12):1259. doi: 10.1176/appi.ajp.2015.15070899. No abstract available.
William Honer, MD
University of British Columbia
First Submitted
January 3, 2006
First Posted
January 6, 2006
Study Start
June 2001
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
January 2004
Date type not reportedRisperidone Maintenance Treatment in Schizophrenia
Contact the study team to confirm eligibility.
This date has not been verified as actual or estimated.
Last Updated
May 8, 2006
Record last verified: 2006-01
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Source: ClinicalTrials.gov.
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