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

Condition(s) targeted: Bipolar Disorder

Intervention: Quetiapine Fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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 design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary outcome: Evaluate the incidence of treatment-emergent mania compared to placebo

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Research Site, Birmingham, Alabama, United States

Research Site, Scottsdale, Arizona, United States

Research Site, Torrance, California, United States

Research Site, San Diego, California, United States

Research Site, Cerritos, California, United States

Research Site, Garden Grove, California, United States

Research Site, Orlando, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Winter Park, Florida, United States

Research Site, Maitland, Florida, United States

Research Site, Boise, Idaho, United States

Research Site, Oak Brook, Illinois, United States

Research Site, Overbrook Terrace, Illinois, United States

Research Site, Shreveport, Louisiana, United States

Research Site, Baltimore, Maryland, United States

Research Site, Clementon, New Jersey, United States

Research Site, Moorestown, New Jersey, United States

Research Site, Albuquerque, New Mexico, United States

Research Site, Brooklyn, New York, United States

Research Site, Staten Island, New York, United States

Research Site, New York, New York, United States

Research Site, Raleigh, North Carolina, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Dayton, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Portland, Oregon, United States

Research Site, Philadelphia, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Charleston, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Austin, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Salt Lake City, Utah, United States

Research Site, Bellevue, Washington, United States

Research Site, Kirkland, Washington, United States

Research Site, Seattle, Washington, United States

Starting date: June 2004
Last updated: February 14, 2006