Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00328978|
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : March 25, 2009
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|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorders||Drug: Quetiapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|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|
- 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.
- To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Calgary, Alberta, Canada|
|Edmonton, Alberta, Canada|
|West Claresholm, Alberta, Canada|
|Canada, British Columbia|
|Victoria, British Columbia, Canada|
|White Rock, British Columbia, Canada|
|Winnipeg, Manitoba, Canada|
|Canada, Nova Scotia|
|Sydney, Nova Scotia, Canada|
|Kingston, Ontario, Canada|
|London, Ontario, Canada|
|Markham, Ontario, Canada|
|Mississauga, Ontario, Canada|
|Ottawa, Ontario, Canada|
|Windsor, Ontario, Canada|
|Montreal, Quebec, Canada|
|Quebec City, Quebec, Canada|
|Verdun, Quebec, Canada|
|Saskatoon, Saskatchewan, Canada|
|Study Director:||AstraZeneca Canada Medical Director, MD||AstraZeneca|
|Other Study ID Numbers:||
|First Posted:||May 24, 2006 Key Record Dates|
|Last Update Posted:||March 25, 2009|
|Last Verified:||March 2009|
Schizophrenia Spectrum and Other Psychotic Disorders
Central Nervous System Depressants
Physiological Effects of Drugs