Phase III/Seroquel SR Bipolar Depression Monotherapy - US
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression
1 other identifier
interventional
400
1 country
54
Brief Summary
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2006
Shorter than P25 for phase_3
54 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
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 12, 2007
CompletedFirst Posted
Study publicly available on registry
January 15, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMarch 25, 2009
March 1, 2009
January 12, 2007
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in depression symptoms by final visit as measured by the MADRS total score
Secondary Outcomes (1)
Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
- Outpatient status at enrollment
You may not qualify if:
- Patients with \>8 mood episodes during the past 12 years
- Use of prohibited medications
- Substance or alcohol abuse or dependence
- Current suicide risk or suicide attempt within last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (54)
Research Site
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Cerritos, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Pico Rivera, California, United States
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San Diego, California, United States
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Wildomar, California, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Maitland, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Smyrna, Georgia, United States
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Honolulu, Hawaii, United States
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Joliet, Illinois, United States
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Greenwood, Indiana, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Rockville, Maryland, United States
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Farmington Hills, Michigan, United States
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St Louis, Missouri, United States
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, 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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Beachwood, Ohio, 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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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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South Kirkland, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine Datto, MD
AstraZeneca
- STUDY DIRECTOR
Larisa Acevedo, Ph.D
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
January 12, 2007
First Posted
January 15, 2007
Study Start
December 1, 2006
Study Completion
June 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03