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Status:

COMPLETED

Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

Lead Sponsor:

GlaxoSmithKline

Conditions:

Depressive Disorder, Major

Eligibility:

All Genders

18-64 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
  • Capable of giving informed consent and willing to comply with the study requirements.
  • Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.
  • Exclusion Criteria:
  • Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
  • Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
  • Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
  • Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
  • Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2006

    Estimated Enrollment :

    348 Patients enrolled

    Trial Details

    Trial ID

    NCT00413023

    Start Date

    June 1 2005

    End Date

    September 1 2006

    Last Update

    October 28 2016

    Active Locations (39)

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    Page 1 of 10 (39 locations)

    1

    GSK Investigational Site

    Buenos Aires, Buenos Aires, Argentina, C1122AAN

    2

    GSK Investigational Site

    Córdoba, Córdoba Province, Argentina, 5000

    3

    GSK Investigational Site

    Buenos Aires, Argentina, C1062ABF

    4

    GSK Investigational Site

    Buenos Aires, Argentina, C1425BPK