Back to resultsSafety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
Primary Purpose
Bipolar Disorder, Depression, Bipolar
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SEROQUEL (quetiapine fumarate) Tablets
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar Depression
Eligibility Criteria
Inclusion Criteria: Written Informed Consent; Bipolar disorder with most recent episode depressed; Outpatient status Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00060489
Brief Title
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression, Bipolar
Keywords
Bipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SEROQUEL (quetiapine fumarate) Tablets
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written Informed Consent;
Bipolar disorder with most recent episode depressed;
Outpatient status
Exclusion Criteria:
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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
La Mesa
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Winter Park
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Smyrna
State/Province
Georgia
Country
United States
City
Oakbrook
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Clementon
State/Province
New Jersey
Country
United States
City
Moorestown
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Staten Island
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Falls Church
State/Province
Virginia
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
City
Kirkland
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19956459
Citation
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
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