Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
1 other identifier
interventional
N/A
1 country
27
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2002
Shorter than P25 for phase_3
27 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
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 6, 2003
CompletedFirst Posted
Study publicly available on registry
May 8, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedJanuary 26, 2011
January 1, 2011
1 year
May 6, 2003
January 25, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Written Informed Consent;
- Bipolar disorder with most recent episode depressed;
- Outpatient status
You may not qualify if:
- Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (27)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
La Mesa, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Winter Park, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Smyrna, Georgia, United States
Unknown Facility
Oak Brook, Illinois, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Clementon, New Jersey, United States
Unknown Facility
Moorestown, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Falls Church, Virginia, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Kirkland, 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2003
First Posted
May 8, 2003
Study Start
September 1, 2002
Primary Completion
September 1, 2003
Study Completion
September 1, 2003
Last Updated
January 26, 2011
Record last verified: 2011-01