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Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00328978
First received: May 22, 2006
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328978

Locations
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
AstraZeneca
Investigators
Study Director: AstraZeneca Canada Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00328978     History of Changes
Other Study ID Numbers: DC-990-0165, D1441C00023
Study First Received: May 22, 2006
Last Updated: March 24, 2009
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
schizophrenia
schizoaffective disorders

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013