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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00272584
First received: January 3, 2006
Last updated: May 5, 2006
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Psychosis, Schizophrenia
Drug: Risperidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: International Study of Improving Treatment for the Most Severely Ill With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: June 2001
Estimated Study Completion Date: January 2004
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 be augmented with placebo for 7 days. Any subject with a reduction in PANSS total score of 20% or greater will be discontinued from the study. Beginning on day 8, subjects will be randomized to continued augmentation of clozapine with placebo, or to augmentation with risperidone. The initial daily dose of risperidone will be 1.0 mg, increased in 1.0 mg increments to a total of 3.0 mg/day over a two week period. Subjects unable to tolerate at least one tablet of study medication will be dropped from the study. At the end of 8 weeks following randomization, at the choice of the investigator, open-label risperidone augmentation can be started.

The primary outcome measure is the PANSS total score at week 9. Subjects will be classified as responders if the improvement in PANSS total score is 20% or greater, and the proportion of responders in each group will be determined. Complementary outcome measures will be the CGI severity score, CGI improvement score, and SOFAS score. Safety and tolerance will be assessed by reports of adverse events and clinically significant changes in vital signs, weight, waist circumference, extrapyramidal side effects, metabolic and hematological measures.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272584

Locations
Canada, British Columbia
UBC Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: William Honer, MD University of British Columbia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00272584     History of Changes
Other Study ID Numbers: C0-0280
Study First Received: January 3, 2006
Last Updated: May 5, 2006
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Psychosis, schizophrenia, schizoaffective, clozapine, risperidone

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014