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Completed

NCT Number: NCT00272584

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

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.

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Key information

Conditions

Psychosis, Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UBC Hospital

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risperidone

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. To determine if risperidone augmentation has effects on cognition, a neuropsychological test battery will be carried out.

  4. The predictive value of neurocognitive testing, and DNA analysis for results of risperidone augmentation will be studied.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

International Study of Improving Treatment for the Most Severely Ill With Schizophrenia

Important dates

Study start
2001
Study completion
2004
First posted
Jan 6, 2006
Registry last updated
May 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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