Status:
COMPLETED
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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).
Eligibility Criteria
Inclusion
- 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
- Women who are pregnant or who will be breastfeeding during the study
- Patients with a history of:
- 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
Key Trial Info
Start Date :
April 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2014
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT01844115
Start Date
April 30 2013
End Date
March 31 2014
Last Update
December 18 2019
Active Locations (36)
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1
Forest Investigative Site 023
Birmingham, Alabama, United States, 35216
2
Forest Investigative Site 013
Phoenix, Arizona, United States, 85032
3
Forest Investigative Site 036
Beverly Hills, California, United States, 90210
4
Forest Investigative Site 001
Costa Mesa, California, United States, 92626