Efficacy and Safety Study of ABT-436 in Major Depressive Disorder

Last updated: October 4, 2013
Sponsor: AbbVie (prior sponsor, Abbott)
Overall Status: Terminated

Phase

2

Condition

Depression (Major/severe)

Affective Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT01741142
M11-733
  • Ages 18-65
  • All Genders

Study Summary

The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a primary Diagnostic and Statistical Manual of Mental Disorders-FourthEdition-Text Revision diagnosis of major depressive disorder without psychoticfeatures

  • No current antidepressant treatment within 7 half-lives or 2 weeks, whichever islonger, prior to Day minus 1.

  • Can safely be treated on an outpatient basis.

  • A condition of general good physical health.

  • Surgically sterile, using a highly effective method of birth control or (if female) atleast 1 year post menopausal.

Exclusion

Exclusion Criteria:

  • History of hypersensitivity, intolerance or adverse reaction to escitalopram that ledto discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.

  • Inadequate response to more than two different antidepressant medications during thecurrent major depressive episode.

  • History of electroconvulsive therapy, vagal nerve stimulation or deep brainstimulation.

  • History of transcranial magnetic stimulation during the current major depressiveepisode.

  • Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.

Study Design

Total Participants: 19
Study Start date:
January 01, 2012
Estimated Completion Date:
August 31, 2015

Connect with a study center

  • Site Reference ID/Investigator# 85593

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87228

    Garden Grove, California 92845
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87214

    National City, California 91950
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87220

    Oakland, California 94612
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87215

    Bradenton, Florida 34201
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87225

    South Miami, Florida 33143
    United States

    Site Not Available

  • Site Reference ID/Investigator# 85594

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Site Reference ID/Investigator# 85580

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87227

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87223

    New York, New York 10128
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87217

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87226

    Portland, Oregon 97210
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87221

    Philadelphia, Pennsylvania 19139
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87219

    Austin, Texas 78731
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87216

    Dallas, Texas 75231
    United States

    Site Not Available

  • Site Reference ID/Investigator# 87933

    Houston, Texas 77008
    United States

    Site Not Available

  • Site Reference ID/Investigator# 88874

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Site Reference ID/Investigator# 88876

    Seattle, Washington 98104
    United States

    Site Not Available

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