Safety, Efficacy and Tolerability of Vilazodone in Major Depressive Disorder



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:November 2011
End Date:May 2013
Contact:Sandra Beaird, PhD
Email:info@forestpharm.com
Phone:1-800-678-1605

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A Double-Blind, Placebo-Controlled, Fixed-Dose Study of Vilazodone in Patients With Major Depressive Disorder


The purpose of this study is further characterize the efficacy, safety and tolerability of a
single fixed dose level of vilazodone compared to placebo in patients with major depressive
disorder.


Inclusion Criteria:

- Men and women, 18-70 years of age

- Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

- The patient's current major depressive episode must be at least 8 weeks and no longer
than 12 months in duration

Exclusion Criteria:

- Women who are pregnant, women who will be breastfeeding during the study, and women
of childbearing potential who are not practicing a reliable method of birth control

- Patients with a history of meeting DSM-IV-TR criteria for:

- any manic, hypomanic or mixed episode, including bipolar disorder and
substance-induced manic, hypomanic, or mixed episode;

- any depressive episode with psychotic or catatonic features;

- panic disorder with or without agoraphobia;

- obsessive-compulsive disorder;

- Schizophrenia, schizoaffective, or other psychotic disorder;

- bulimia or anorexia nervosa;

- presence of borderline personality disorder or antisocial personality disorder;

- mental retardation, dementia, amnesia, or other cognitive disorders

- Patients who are considered a suicide risk
We found this trial at
14
sites
Seattle, Washington 98104
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Seattle, WA
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Atlanta, Georgia 30328
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Atlanta, GA
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Bellevue, Washington 98007
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Bellevue, WA
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Broomall, Pennsylvania 19008
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Broomall, PA
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Cleveland, Ohio 44106
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Cleveland, OH
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Costa Mesa, California 92626
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Costa Mesa, CA
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Houston, Texas 77008
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Houston, TX
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Lincoln, Rhode Island 02865
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Lincoln, RI
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Memphis, Tennessee 38119
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Memphis, TN
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Orange, California 92868
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Orange, CA
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Pembroke Pines, Florida 33028
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Pembroke Pines, FL
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Riverside, California 92506
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Riverside, CA
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Tampa, Florida 33606
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Tampa, FL
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Towson, Maryland 21204
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Towson, MD
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