Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders

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

Phase

3

Condition

Depression (Adult And Geriatric)

Affective Disorders

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT00326144
D1448C00003
OPAL
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders 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:

  • Patient is able to provide written informed consent before beginning any study relatedprocedures

  • Patient has a documented clinical diagnosis of major depressive disorder

  • Patient is able to understand and comply with the requirements of the study, as judgedby a study investigator

Exclusion

Exclusion Criteria:

  • Patients with a history of non-compliance as judged by the study investigator

  • Patients with a known lack of response to previous treatment with quetiapine

  • Patients who have participated in a clinical trial within 4 weeks of randomization

Study Design

Total Participants: 310
Study Start date:
April 01, 2006
Estimated Completion Date:
May 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

    Anaheim, California
    United States

    Site Not Available

  • Research Site

    El Centro, California
    United States

    Site Not Available

  • Research Site

    Garden Grove, California
    United States

    Site Not Available

  • Research Site

    National City, California
    United States

    Site Not Available

  • Research Site

    Riverside, California
    United States

    Site Not Available

  • Research Site

    Hartford, Connecticut
    United States

    Site Not Available

  • Research Site

    Wilmington, Delaware
    United States

    Site Not Available

  • Research Site

    Altamonte Springs, Florida
    United States

    Site Not Available

  • Research Site

    DeLand, Florida
    United States

    Site Not Available

  • Research Site

    Maitland, Florida
    United States

    Site Not Available

  • Research Site

    New Port Richey, Florida
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia
    United States

    Site Not Available

  • Research Site

    Decatur, Georgia
    United States

    Site Not Available

  • Research Site

    Roswell, Georgia
    United States

    Site Not Available

  • Research Site

    Naperville, Illinois
    United States

    Site Not Available

  • Research Site

    Indianapolis, Indiana
    United States

    Site Not Available

  • Research Site

    Lafayette, Indiana
    United States

    Site Not Available

  • Research Site

    Owensboro, Kentucky
    United States

    Site Not Available

  • Research Site

    New Orleans, Louisiana
    United States

    Site Not Available

  • Research Site

    Braintree, Massachusetts
    United States

    Site Not Available

  • Research Site

    Cambridge, Massachusetts
    United States

    Site Not Available

  • Research Site

    Pittsfield, Massachusetts
    United States

    Site Not Available

  • Research Site

    Minneapolis, Minnesota
    United States

    Site Not Available

  • Research Site

    St. Louis, Missouri
    United States

    Site Not Available

  • Research SIte

    Staten Island, New York
    United States

    Site Not Available

  • Research Site

    Avon Lake, Ohio
    United States

    Site Not Available

  • Research Site

    Cincinnati, Ohio
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Research Site

    Allentown, Pennsylvania
    United States

    Site Not Available

  • Research Site

    Memphis, Tennessee
    United States

    Site Not Available

  • Research Site

    DeSoto, Texas
    United States

    Site Not Available

  • Research Site

    Houston, Texas
    United States

    Site Not Available

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