Phase 3 /Seroquel SR Acute Mania Monotherapy - US

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

Phase

3

Condition

Bipolar Disorder

Manic Disorders

Affective Disorders

Treatment

N/A

Clinical Study ID

NCT00422123
D144CC00004
  • 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 Mania for 3 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 Disorder, with most recent episode being manic ormixed

  • Inpatient hospital admission for the first 4 days of study treatment

Exclusion

Exclusion Criteria:

  • >8 mood episodes within the last 12 months

  • Use of prohibited medication

  • Substance or alcohol abuse or dependence

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

Study Design

Total Participants: 447
Study Start date:
January 01, 2007
Estimated Completion Date:
July 31, 2007

Connect with a study center

  • Research Site

    Phoenix, 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

    Garden Grove, 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

    Santa Ana, California
    United States

    Site Not Available

  • Research Site

    Torrance, California
    United States

    Site Not Available

  • Research Site

    Denver, Colorado
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia
    United States

    Site Not Available

  • Research Site

    Aventura, Florida
    United States

    Site Not Available

  • Research Site

    East Bradenton, Florida
    United States

    Site Not Available

  • Research Sitew

    Fort Lauderdale, Florida
    United States

    Site Not Available

  • Research Site

    Hollywood, Florida
    United States

    Site Not Available

  • Research Site

    Leesburg, Florida
    United States

    Site Not Available

  • Research Site

    Tampa, Florida
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia
    United States

    Site Not Available

  • Research Site

    Honolulu, Hawaii
    United States

    Site Not Available

  • Research Site

    Hoffman Estates, Illinois
    United States

    Site Not Available

  • Research Site

    Naperville, Illinois
    United States

    Site Not Available

  • Research Site

    Oak Brook Terrace, 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

    Newton, Kansas
    United States

    Site Not Available

  • Research Site

    Wichita, Kansas
    United States

    Site Not Available

  • Research Site

    Lake Charles, Louisiana
    United States

    Site Not Available

  • Research Site

    New Orleans, Louisiana
    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

    St. Louis, Missouri
    United States

    Site Not Available

  • Research Site

    Kenilworth, New Jersey
    United States

    Site Not Available

  • Research Site

    Willingboro, New Jersey
    United States

    Site Not Available

  • Research Site

    Elmsford, New York
    United States

    Site Not Available

  • Research Site

    Holliswood, New York
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina
    United States

    Site Not Available

  • Research Site

    Beachwood, Ohio
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Research Site

    Moon Township, Pennsylvania
    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

    Nashville, Tennessee
    United States

    Site Not Available

  • Research Site

    Austin, Texas
    United States

    Site Not Available

  • Research Site

    Desoto, Texas
    United States

    Site Not Available

  • Research Site

    Houston, Texas
    United States

    Site Not Available

  • Research Site

    Irving, Texas
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas
    United States

    Site Not Available

  • Research Site

    Arlington, Virginia
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia
    United States

    Site Not Available

  • Research Site

    Bellevue, Washington
    United States

    Site Not Available

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