Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression
1 other identifier
interventional
530
1 country
36
Brief Summary
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2004
Shorter than P25 for phase_3
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 3, 2004
CompletedFirst Posted
Study publicly available on registry
June 7, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJanuary 4, 2013
January 1, 2013
June 3, 2004
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary Outcomes (1)
Evaluate the incidence of treatment-emergent mania compared to placebo
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status
You may not qualify if:
- More than 8 mood episodes in the past year from screen (visit 1);
- A current Axis I disorder other than bipolar disorder within 6 months of screening;
- patients with clinically significant abnormal laboratory findings in the investigator's judgment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (36)
Research Site
Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Cerritos, California, United States
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Garden Grove, California, United States
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San Diego, California, United States
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Torrance, California, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Orlando, Florida, United States
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Winter Park, Florida, United States
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Boise, Idaho, United States
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Oak Brook, Illinois, United States
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Overbrook Terrace, Illinois, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Clementon, New Jersey, United States
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Moorestown, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Salt Lake City, Utah, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
Related Publications (1)
Lydiard RB, Culpepper L, Schioler H, Gustafsson U, Paulsson B. Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659.
PMID: 19956459DERIVED
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
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2004
First Posted
June 7, 2004
Study Start
June 1, 2004
Study Completion
August 1, 2005
Last Updated
January 4, 2013
Record last verified: 2013-01