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

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

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: ABT-436
* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-436<br>Subject receiving ABT-436 | Drug: ABT-436<br>* Subjects receiving ABT-436<br>|
| Active Comparator: Escitalopram<br>Subject receiving escitalopram. | Drug: Escitalopram<br>* Subjects receiving escitalopram<br>|
| Placebo Comparator: Placebo<br>Subject receiving placebo | Drug: Placebo<br>* Subject receiving placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. | Primary efficacy variable will be change from baseline to Week 6 visit on Montgomery-Asberg Depression Rating Scale (MADRS) total score. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale. | Secondary efficacy variables include change from Baseline to Week 6 on clinician-rated Hamilton Depression Rating Scale. | Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder