Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Last updated: March 24, 2009
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Bipolar Disorder

Affective Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00422214
D144CC00002
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of written informed consent

  • Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder

  • Outpatient status at enrollment

Exclusion

Exclusion Criteria:

  • Patients with >8 mood episodes during the past 12 years

  • Use of prohibited medications

  • Substance or alcohol abuse or dependence

  • Current suicide risk or suicide attempt within last 6 months.

Study Design

Total Participants: 400
Study Start date:
December 01, 2006
Estimated Completion Date:
June 30, 2007

Connect with a study center

  • Research Site

    Birmingham, Alabama
    United States

    Site Not Available

  • Research Site

    Phoenix, Arizona
    United States

    Site Not Available

  • Research Site

    Scottsdale, Arizona
    United States

    Site Not Available

  • Research Site

    Little Rock, Arkansas
    United States

    Site Not Available

  • Research Site

    Cerritos, California
    United States

    Site Not Available

  • Research Site

    La Mesa, California
    United States

    Site Not Available

  • Research Site

    Los Angeles, California
    United States

    Site Not Available

  • Research Site

    Newport Beach, California
    United States

    Site Not Available

  • Research Site

    Northridge, California
    United States

    Site Not Available

  • Research Site

    Oceanside, California
    United States

    Site Not Available

  • Research Site

    Pico Rivera, California
    United States

    Site Not Available

  • Research Site

    San Diego, California
    United States

    Site Not Available

  • Research Site

    Wildomar, California
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia
    United States

    Site Not Available

  • Research Site

    Bradenton, Florida
    United States

    Site Not Available

  • Research Site

    Fort Lauderdale, Florida
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida
    United States

    Site Not Available

  • Research Site

    Leesburg, Florida
    United States

    Site Not Available

  • Research Site

    Maitland, Florida
    United States

    Site Not Available

  • Research Site

    North Miami, Florida
    United States

    Site Not Available

  • Research Site

    Orlando, Florida
    United States

    Site Not Available

  • Research Site

    Tampa, Florida
    United States

    Site Not Available

  • Research Site

    West Palm Beach, Florida
    United States

    Site Not Available

  • Research Site

    Smyrna, Georgia
    United States

    Site Not Available

  • Research Site

    Honolulu, Hawaii
    United States

    Site Not Available

  • Research Site

    Joliet, Illinois
    United States

    Site Not Available

  • Research Site

    Greenwood, Indiana
    United States

    Site Not Available

  • Research Site

    Indianapolis, Indiana
    United States

    Site Not Available

  • Research Site

    Wichita, Kansas
    United States

    Site Not Available

  • Research Site

    Shreveport, Louisiana
    United States

    Site Not Available

  • Research Site

    Rockville, Maryland
    United States

    Site Not Available

  • Research Site

    Farmington Hills, Michigan
    United States

    Site Not Available

  • Research Site

    St. Louis, Missouri
    United States

    Site Not Available

  • Research Site

    Cherry Hill, New Jersey
    United States

    Site Not Available

  • Research Site

    Clementon, New Jersey
    United States

    Site Not Available

  • Research Site

    Brooklyn, New York
    United States

    Site Not Available

  • Research Site

    New York, New York
    United States

    Site Not Available

  • Research Site

    Staten Island, New York
    United States

    Site Not Available

  • Research Site

    Beachwood, Ohio
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio
    United States

    Site Not Available

  • Research Site

    Dayton, Ohio
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Research Site

    Portland, Oregon
    United States

    Site Not Available

  • Research Site

    Salem, Oregon
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Research Site

    Charleston, South Carolina
    United States

    Site Not Available

  • Research Site

    Memphis, Tennessee
    United States

    Site Not Available

  • Research Site

    Dallas, Texas
    United States

    Site Not Available

  • Research Site

    Houston, Texas
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia
    United States

    Site Not Available

  • Research Site

    Virginia Beach, Virginia
    United States

    Site Not Available

  • Research Site

    Bellevue, Washington
    United States

    Site Not Available

  • Research Site

    Seattle, Washington
    United States

    Site Not Available

  • Research Site

    South Kirkland, Washington
    United States

    Site Not Available

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