Phase 3 /Seroquel SR Acute Mania Monotherapy - US
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
1 other identifier
interventional
447
1 country
51
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 Mania for 3 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 Jan 2007
Shorter than P25 for phase_3
51 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
January 1, 2007
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
July 1, 2007
CompletedMarch 25, 2009
March 1, 2009
January 12, 2007
March 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to final visit in the YMRS total score
Secondary Outcomes (1)
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
- Inpatient hospital admission for the first 4 days of study treatment
You may not qualify if:
- \>8 mood episodes within the last 12 months
- Use of prohibited medication
- 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 (51)
Research Site
Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Cerritos, California, United States
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Garden Grove, 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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Santa Ana, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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EAST Bradenton, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Leesburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Honolulu, Hawaii, United States
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Hoffman Estates, Illinois, United States
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Naperville, Illinois, United States
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OAK Brook Terrace, Illinois, United States
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Greenwood, Indiana, United States
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Indianapolis, Indiana, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Rockville, Maryland, United States
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St Louis, Missouri, United States
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Kenilworth, New Jersey, United States
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Willingboro, New Jersey, United States
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Elmsford, New York, United States
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Holliswood, New York, United States
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Durham, North Carolina, United States
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Beachwood, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Moon Township, Pennsylvania, 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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Nashville, Tennessee, United States
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Austin, Texas, United States
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DeSoto, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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Arlington, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
Related Publications (1)
Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.
PMID: 22054797DERIVED
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
January 1, 2007
Study Completion
July 1, 2007
Last Updated
March 25, 2009
Record last verified: 2009-03