Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorders
Intervention: Quetiapine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Canada Medical Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study
Primary outcome: 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: To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, West Claresholm, Alberta, Canada
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, 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, Ottawa, Ontario, Canada
Research Site, Mississauga, Ontario, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Markham, Ontario, Canada
Research Site, Windsor, Ontario, Canada
Research Site, London, Ontario, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Quebec City, Quebec, Canada
Research Site, Verdun, Quebec, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Additional Information
Starting date: October 2003
Last updated: May 22, 2006
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