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 |
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.
We found this trial at
18
sites
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