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

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

Phase

3

Condition

Depression (Major/severe)

Mood Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT00326105
D1448C00006
PEARL
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment.

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: 450
Study Start date:
April 01, 2006
Estimated Completion Date:
July 31, 2007

Connect with a study center

  • Research Site

    Phoenix, Arizona
    United States

    Site Not Available

  • Research Site

    El Centro, California
    United States

    Site Not Available

  • Research Site

    Irvine, California
    United States

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  • Research Site

    Oceanside, California
    United States

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  • Research Site

    San Diego, California
    United States

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  • Research Site

    Pueblo, Colorado
    United States

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  • Research Site

    Coral Springs, Florida
    United States

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  • Research Site

    Deland, Florida
    United States

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  • Research Site

    Gainsville, Florida
    United States

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  • Research Site

    Hialeah, Florida
    United States

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  • Research Site

    Jacksonville, Florida
    United States

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  • Research Site

    Miami, Florida
    United States

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  • Research Site

    Orlando, Florida
    United States

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  • Research Site

    West Palm Beach, Florida
    United States

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  • Research Site

    Atlanta, Georgia
    United States

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  • Research Site

    Roswell, Georgia
    United States

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  • Research Site

    Hoffman Estates, Illinois
    United States

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  • Research Site

    Naperville, Illinois
    United States

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  • Research Site

    Oak Brook, Illinois
    United States

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  • Research Site

    Indianapolis, Indiana
    United States

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  • Research Site

    Lafayette, Indiana
    United States

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    Valparaiso, Indiana
    United States

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    Prairie Village, Kansas
    United States

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  • Research Site

    Wichita, Kansas
    United States

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  • Research Site

    Shreveport, Louisiana
    United States

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  • Research SIte

    Glen Burnie, Maryland
    United States

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  • Research Site

    Braintree, Massachusetts
    United States

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  • Research Site

    Springfield, Massachusetts
    United States

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  • Research Site

    Clinton Township, Michigan
    United States

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  • Research Site

    Kalamazoo, Michigan
    United States

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  • Research Site

    Royal Oak, Michigan
    United States

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  • Research Site

    St Charles, Missouri
    United States

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    St. Louis, Missouri
    United States

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  • Research Site

    Cherry Hill, New Jersey
    United States

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  • Research Site

    Clementon, New Jersey
    United States

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    Cedarhurst, New York
    United States

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  • Research Site

    New York, New York
    United States

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  • Research Site

    Olean, New York
    United States

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  • Research Site

    Rochester, New York
    United States

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  • Research Site

    Staten Island, New York
    United States

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  • Research Site

    Beechwood, Ohio
    United States

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  • Research Site

    Toledo, Ohio
    United States

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  • Research Site

    Norman, Oklahoma
    United States

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  • Research Site

    Oklahoma City, Oklahoma
    United States

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  • Research Site

    Philadelphia, Pennsylvania
    United States

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  • Research Site

    Lincoln, Rhode Island
    United States

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  • Research Site

    Columbia, South Carolina
    United States

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  • Research Site

    Memphis, Tennessee
    United States

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  • Research Site

    Friendswood, Texas
    United States

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  • Research Site

    Houston, Texas
    United States

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  • Research Site

    San Antonio, Texas
    United States

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  • Research SIte

    Wichita Falls, Texas
    United States

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  • Research Site

    Salt Lake City, Utah
    United States

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  • Research Site

    Arlington, Virginia
    United States

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  • Research Site

    Richmond, Virginia
    United States

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  • Research Site

    Bellevue, Washington
    United States

    Site Not Available

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