AZD7268 Safety and Tolerability Study

Last updated: April 11, 2012
Sponsor: AstraZeneca
Overall Status: Completed

Phase

2

Condition

Depression (Major/severe)

Affective Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT01020799
D1151C00005
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed, written, and dated Informed Consent prior to any study specificprocedures

  • Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:

  • 296.2x Major Depressive Disorder, Single Episode, or

  • 296.3x Major Depressive Disorder, Recurrent

Exclusion

Exclusion Criteria:

  • Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxietydisorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosisshould have been made at least 6 months before enrollment

  • Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on thepatient's current psychiatric status

  • Patients whose current episode of depression started less than 4 weeks beforeenrollment

Study Design

Total Participants: 247
Study Start date:
November 01, 2009
Estimated Completion Date:
April 30, 2010

Connect with a study center

  • Research Site

    Birmingham, Alabama
    United States

    Site Not Available

  • Research Site

    Garden Grove, California
    United States

    Site Not Available

  • Research Site

    San Diego, California
    United States

    Site Not Available

  • Research Site

    New Haven, Connecticut
    United States

    Site Not Available

  • Research Site

    Bradenton, Florida
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia
    United States

    Site Not Available

  • Research Site

    Rockville, Maryland
    United States

    Site Not Available

  • Research Site

    Cedarhurst, New York
    United States

    Site Not Available

  • Research Site

    New York, New York
    United States

    Site Not Available

  • Research Site

    Rochester, New York
    United States

    Site Not Available

  • Research Site

    Dayton, Ohio
    United States

    Site Not Available

  • Research Site

    Portland, Oregon
    United States

    Site Not Available

  • Research Site

    Memphis, Tennessee
    United States

    Site Not Available

  • Research Site

    Friendswood, Texas
    United States

    Site Not Available

  • Research Site

    Bellevue, Washington
    United States

    Site Not Available

  • Research Site

    Seattle, Washington
    United States

    Site Not Available

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