Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272584
Status:
COMPLETED
Last Update Posted:
2006-05-08
First Post:
2006-01-03
Brief Title:
CARE Study Improving Treatment for the Most Severely Ill With Schizophrenia
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
International Study of Improving Treatment for the Most Severely Ill With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 study clozapine and risperidone are fully approved for the treatment of schizophrenia
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 10 mg increased in 10 mg increments to a total of 30 mgday 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None