Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder



Status:Completed
Conditions:Anxiety, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:11/23/2013
Start Date:June 2012
End Date:February 2014
Contact:Sandra Beaird, PhD
Email:FRXClinTrials@frx.com
Phone:1-800-678-1605

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A Double-blind, Placebo-Controlled Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.


The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone
relative to placebo in the treatment of generalized anxiety disorder (GAD)


Inclusion Criteria:

- Male and female, 18 - 70 years of age

- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)

- Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

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 or 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 significant cognitive disorders

- Patients who are considered a suicide risk
We found this trial at
39
sites
Memphis, Tennessee 38119
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Atlanta, Georgia 30328
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Atlanta, GA
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Austin, Texas 78731
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Austin, TX
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Baltimore, Maryland 21208
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Bellevue, Washington 98007
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Berlin, New Jersey 08009
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Berlin, NJ
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Bismarck, North Dakota 58501
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Bismarck, ND
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Boca Raton, Florida 33432
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Brockton, Massachusetts 02301
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Cambridge, Massachusetts 02138
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Cedarhurst, New York 11516
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Charlottesville, Virginia 22911
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Charlottesville, VA
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Chicago, Illinois 60634
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Chicago, IL
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Cleveland, Ohio 44109
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Cleveland, OH
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Dayton, Ohio 45414
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Decatur, Georgia 30030
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Decatur, GA
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Dothan, Alabama 36303
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Fort Myers, Florida 33912
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Glendale, California 91204
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Lake Charles, Louisiana 70629
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Las Vegas, Nevada 89103
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Little Rock, Arkansas 72211
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New York, New York 10168
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New York, New York 10003
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New York, New York 10023
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Norwich, Connecticut 06360
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Oklahoma City, Oklahoma 73112
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73116
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Pembroke Pines, Florida 33028
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Portland, Oregon 97210
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Salt Lake City, Utah 84106
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San Francisco, California 94143
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Schaumburg, Illinois 60194
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Seattle, Washington 98104
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St. Louis, Missouri 63104
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Temecula, California 92591
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Topeka, Kansas 66606
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Waterbury, Connecticut 06708
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Wichita, Kansas 67207
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Wichita, KS
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