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Trial record 1 of 1 for:    NCT00328978
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Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

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ClinicalTrials.gov Identifier: NCT00328978
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : March 25, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorders Drug: Quetiapine Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
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.
Study Start Date : October 2003
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328978

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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
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Study Director: AstraZeneca Canada Medical Director, MD AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00328978    
Other Study ID Numbers: DC-990-0165
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
schizoaffective disorders
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs