Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

• Status: Completed
• Trial end date: 2014-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Vilazodone Hydrochloride

Criteria

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

• History of meeting DSM-IV-TR criteria for any of the following:

• 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