Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder
Status: | Completed |
---|---|
Conditions: | Anxiety, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/23/2013 |
Start Date: | January 2013 |
End Date: | April 2014 |
Contact: | Sandra Beaird, PhD |
Email: | info@forestpharm.com |
Phone: | 1-800-678-1605 |
A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone 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, 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
29
sites
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