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



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:5/27/2013
Start Date:January 2012
End Date:August 2013
Contact:Jeanne Martin, BS
Email:jeanne.m.martin@abbvie.com
Phone:847-938-7814

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A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder


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


Inclusion Criteria:

- Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth
Edition-Text Revision diagnosis of major depressive disorder without psychotic
features

- 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:

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

- 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.
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