Back to resultsSeroquel STACK Study in Schizophrenic or Schizoaffective Subjects
Primary Purpose
Schizophrenia, Schizoaffective Disorders
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizoaffective disorders
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Men and women, age 18-65 years with persistent positive or negative symptoms with a PANSS total score of ≥ 70 and < 110 and a Clinical Global Improvement (CGI)- Severity of Illness score of at least 4 (moderately ill) at screening. Subjects may be treated as in- or out-patients. Subjects must give written informed consent. Exclusion Criteria: Subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation. Female of childbearing potential, unless the subject is using a reliable method of contraception Subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded. Laboratory test results outside the range of reference considered by the investigator to be clinically significant. Inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.
Sites / Locations
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Outcomes
Primary Outcome Measures
To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Secondary Outcome Measures
To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00328978
Brief Title
Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
Official Title
A Canadian, Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment With Higher Doses of Quetiapine Fumarate (Seroquel®) Greater Than 800 mg/Day in Schizophrenic or Schizoaffective Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to assess and compare the side effect profile, safety, tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially- responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day of quetiapine during 8 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorders
Keywords
schizophrenia, schizoaffective disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Primary Outcome Measure Information:
Title
To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Secondary Outcome Measure Information:
Title
To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria: Men and women, age 18-65 years with persistent positive or negative symptoms with a PANSS total score of ≥ 70 and < 110 and a Clinical Global Improvement (CGI)- Severity of Illness score of at least 4 (moderately ill) at screening. Subjects may be treated as in- or out-patients. Subjects must give written informed consent.
Exclusion Criteria:
Subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation.
Female of childbearing potential, unless the subject is using a reliable method of contraception
Subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded.
Laboratory test results outside the range of reference considered by the investigator to be clinically significant.
Inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Canada Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
West Claresholm
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
White Rock
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Sydney
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Verdun
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21733490
Citation
Honer WG, MacEwan GW, Gendron A, Stip E, Labelle A, Williams R, Eriksson H; STACK Study Group. A randomized, double-blind, placebo-controlled study of the safety and tolerability of high-dose quetiapine in patients with persistent symptoms of schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012 Jan;73(1):13-20. doi: 10.4088/JCP.10m06194. Epub 2011 Jun 14.
Results Reference
derived
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Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
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