|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00272584 |
|
Date of registration:
|
03/01/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia
|
|
Scientific title:
|
International Study of Improving Treatment for the Most Severely Ill With Schizophrenia |
|
Date of first enrolment:
|
June 2001 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00272584 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
William Honer, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of British Columbia |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Psychosis, Schizophrenia
|
|
Intervention(s)
|
|
Drug: Risperidone
|
|
Primary Outcome(s)
|
|
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(s)
|
|
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 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.
|
|
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.
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|