Safety, Efficacy and Tolerability of Vilazodone in (GAD) 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 or female outpatient, 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

• Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion Criteria:

• Women who are pregnant or who will be breastfeeding during the study

• Patients with a history of:

1. Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode

2. Any depressive episode with psychotic or catatonic features

3. Panic disorder with or without agoraphobia