Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
1 other identifier
interventional
535
1 country
29
Brief Summary
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Jun 2004
Shorter than P25 for phase_3 schizophrenia
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 16, 2004
CompletedFirst Posted
Study publicly available on registry
June 18, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedMarch 25, 2009
March 1, 2009
June 16, 2004
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
Secondary Outcomes (1)
Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.
Interventions
Eligibility Criteria
You may qualify if:
- Patient is able to provide written informed consent before beginning any study related procedures
- Patient has a documented clinical diagnosis of schizophrenia
- Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
You may not qualify if:
- Patients with a history of non-compliance as judged by the study investigator
- Patients with a known lack of response to previous treatment with quetiapine
- Patients who have participated in another drug study within 4 weeks prior to enrollment into this study
- Patients who have previously participated in this study or study D1444C00132
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
Research Site
Birmingham, Alabama, United States
Research Site
Cerritos, California, United States
Unknown Facility
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Ana, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Miami, Florida, United States
Unknown Facility
Oak Brook, Illinois, United States
Research Site
Oakbrook Terrace, Illinois, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Rockville, Maryland, United States
Unknown Facility
Brighton, Massachusetts, United States
Research Site
Jackson, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
Holliswood, New York, United States
Research Site
Lawrence, New York, United States
Research Site
Staten Island, New York, United States
Research Site
Medina, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Norristown, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Sioux Falls, South Dakota, United States
Research Site
Memphis, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Irving, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Kirkland, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Seroquel Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2004
First Posted
June 18, 2004
Study Start
June 1, 2004
Study Completion
September 1, 2005
Last Updated
March 25, 2009
Record last verified: 2009-03