Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083954
• Other study ID #: D1447C00135
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2004
• Last updated: January 3, 2013
• Start date: June 2004
• Est. completion date: August 2005

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Quetiapine Fumarate

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Austin	Texas
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boise	Idaho
United States	Research Site	Brooklyn	New York
United States	Research Site	Cerritos	California
United States	Research Site	Charleston	South Carolina
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clementon	New Jersey
United States	Research Site	Dayton	Ohio
United States	Research Site	Garden Grove	California
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kirkland	Washington
United States	Research Site	Maitland	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Moorestown	New Jersey
United States	Research Site	New York	New York
United States	Research Site	Oak Brook	Illinois
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Overbrook Terrace	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Diego	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Staten Island	New York
United States	Research Site	Torrance	California
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary	Evaluate the incidence of treatment-emergent mania compared to placebo