Efficacy and Safety Study of ABT-436 in Major Depressive Disorder
NCT ID: NCT01741142
Last Updated: 2013-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2012-01-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABT-436
Subject receiving ABT-436
ABT-436
Subjects receiving ABT-436
Escitalopram
Subject receiving escitalopram.
Escitalopram
Subjects receiving escitalopram
Placebo
Subject receiving placebo
Placebo
Subject receiving placebo
Interventions
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ABT-436
Subjects receiving ABT-436
Escitalopram
Subjects receiving escitalopram
Placebo
Subject receiving placebo
Eligibility Criteria
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Inclusion Criteria
* No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, 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) at least 1 year post menopausal.
Exclusion Criteria
* Inadequate response to more than two different antidepressant medications during the current major depressive episode.
* History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
* History of transcranial magnetic stimulation during the current major depressive episode.
* Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.
18 Years
65 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Beatrice Rendenbach-Mueller, PhD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 85593
Little Rock, Arkansas, United States
Site Reference ID/Investigator# 87228
Garden Grove, California, United States
Site Reference ID/Investigator# 87214
National City, California, United States
Site Reference ID/Investigator# 87220
Oakland, California, United States
Site Reference ID/Investigator# 87215
Bradenton, Florida, United States
Site Reference ID/Investigator# 87225
South Miami, Florida, United States
Site Reference ID/Investigator# 85594
Atlanta, Georgia, United States
Site Reference ID/Investigator# 85580
Marlton, New Jersey, United States
Site Reference ID/Investigator# 87227
Brooklyn, New York, United States
Site Reference ID/Investigator# 87223
New York, New York, United States
Site Reference ID/Investigator# 87217
Dayton, Ohio, United States
Site Reference ID/Investigator# 87226
Portland, Oregon, United States
Site Reference ID/Investigator# 87221
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 87219
Austin, Texas, United States
Site Reference ID/Investigator# 87216
Dallas, Texas, United States
Site Reference ID/Investigator# 87933
Houston, Texas, United States
Site Reference ID/Investigator# 88874
Salt Lake City, Utah, United States
Site Reference ID/Investigator# 88876
Seattle, Washington, United States
Countries
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Other Identifiers
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M11-733
Identifier Type: -
Identifier Source: org_study_id