Status:
COMPLETED
Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Schizoaffective Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00328978
Start Date
October 1 2003
End Date
September 1 2005
Last Update
March 25 2009
Active Locations (17)
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1
Research Site
Calgary, Alberta, Canada
2
Research Site
Edmonton, Alberta, Canada
3
Research Site
West Claresholm, Alberta, Canada
4
Research Site
Victoria, British Columbia, Canada