Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00328978

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study
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

Drug Information available for: Quetiapine Quetiapine fumarate

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
West Claresholm, Alberta, Canada
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, 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
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
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

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

Keywords provided by AstraZeneca:

schizophrenia
schizoaffective disorders

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia

Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010