Back to resultsControlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quetiapine Fumarate
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
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Outcomes
Primary Outcome Measures
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary Outcome Measures
Evaluate the incidence of treatment-emergent mania compared to placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00083954
Brief Title
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
Official Title
A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study 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 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
530 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate
Primary Outcome Measure Information:
Title
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary Outcome Measure Information:
Title
Evaluate the incidence of treatment-emergent mania compared to placebo
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:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Research Site
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Overbrook Terrace
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Moorestown
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Seattle
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
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
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