Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
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.
2 other identifiers
interventional
330
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Oct 2003
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 22, 2006
CompletedFirst Posted
Study publicly available on registry
May 24, 2006
CompletedMarch 25, 2009
March 1, 2009
May 22, 2006
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
West Claresholm, Alberta, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
White Rock, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Sydney, Nova Scotia, Canada
Research Site
Kingston, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Markham, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Verdun, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Related Publications (1)
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.
PMID: 21733490DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Canada Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 22, 2006
First Posted
May 24, 2006
Study Start
October 1, 2003
Study Completion
September 1, 2005
Last Updated
March 25, 2009
Record last verified: 2009-03