Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Last updated: March 1, 2012
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Depression (Adult And Geriatric)

Depression (Major/severe)

Depression

Treatment

N/A

Clinical Study ID

NCT00109044
SCT-MD-35
  • Ages 18-80
  • All Genders

Study Summary

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram combination relative to its component monotherapies and to placebo in patients with major depressive disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV)diagnostic criteria for Major Depressive Disorder.

  • The patient's current depressive episode must be at least 12 weeks in duration.

Exclusion

Exclusion Criteria:

  • Women who are pregnant, women who will be breastfeeding during the study, and women ofchildbearing potential who are not practicing a reliable method of birth control.

  • Patients who currently meet DSM-IV criteria for: a. bipolar disorder; b. schizophreniaor any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation orany pervasive developmental disorder or cognitive disorder.

  • Patients who are considered a suicide risk.

  • Patients with a history of seizure disorder, or any history of seizure, stroke,significant head injury, or any other condition that predisposes toward risk ofseizure.

Study Design

Total Participants: 540
Study Start date:
March 01, 2005
Estimated Completion Date:
May 31, 2006

Connect with a study center

  • Southwest Health, Ltd

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Alpine Clinical Research

    Boulder, Colorado 80304
    United States

    Site Not Available

  • Radiant Research, Inc.

    Denver, Colorado 80212
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32806
    United States

    Site Not Available

  • Cunningham Clinical Research, LLC

    Edwardsville, Illinois 62025
    United States

    Site Not Available

  • Midwest Center for Neurobiological Medicine

    Oakbrook Terrace, Illinois 60181
    United States

    Site Not Available

  • Capital Clinical Research Associates

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Summit Research Network (Michigan), Inc.

    Okemos, Michigan 48864
    United States

    Site Not Available

  • CNS Research Institute

    Clementon, New Jersey 08021
    United States

    Site Not Available

  • Center for Emotional Fitness

    Moorestown, New Jersey 08057
    United States

    Site Not Available

  • Eastside Comprehensive Medical Center

    New York, New York 10021
    United States

    Site Not Available

  • Piedmont Medical Research Associates, Inc.

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Claghorn-Lesem Research Clinic

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Croft Group Research Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Dominion Clinical Research

    Midlothian, Virginia 23112-3989
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Summit Research Network (Seattle), LLC

    Seattle, Washington 98104
    United States

    Site Not Available

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