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Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 22, 2006
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorders Drug: Quetiapine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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.

Estimated Enrollment: 330
Study Start Date: October 2003
Study Completion Date: September 2005

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00328978

Canada, Alberta
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
West Claresholm, Alberta, Canada
Canada, British Columbia
Research Site
Victoria, British Columbia, Canada
Research Site
White Rock, British Columbia, Canada
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Research Site
Sydney, Nova Scotia, Canada
Canada, Ontario
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
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Research Site
Quebec City, Quebec, Canada
Research Site
Verdun, Quebec, Canada
Canada, Saskatchewan
Research Site
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Study Director: AstraZeneca Canada Medical Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00328978     History of Changes
Other Study ID Numbers: DC-990-0165
Study First Received: May 22, 2006
Last Updated: March 24, 2009

Keywords provided by AstraZeneca:
schizoaffective disorders

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on August 18, 2017