Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Generalized Anxiety Disorder

In brief

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).

Key facts

Study ID

NCT01844115

Run by

Forest Laboratories

People needed

415

Starts

2013-04-30

Expected to finish

2014-03-31

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 023 — Birmingham, Alabama, United States
• Forest Investigative Site 013 — Phoenix, Arizona, United States
• Forest Investigative Site 036 — Beverly Hills, California, United States
• Forest Investigative Site 001 — Costa Mesa, California, United States
• Forest Investigative Site 009 — Oceanside, California, United States
• Forest Investigative Site 026 — Rancho Mirage, California, United States
• Forest Investigative Site 017 — Sherman Oaks, California, United States
• Forest Investigative Site 034 — Sherman Oaks, California, United States
• Forest Investigative Site 030 — Bradenton, Florida, United States
• Forest Investigative Site 029 — Gainesville, Florida, United States
• Forest Investigative Site 035 — Jacksonville, Florida, United States
• Forest Investigative Site 032 — Orlando, Florida, United States
• Forest Investigative Site 021 — West Palm Beach, Florida, United States
• Forest Investigative Site 025 — Atlanta, Georgia, United States
• Forest Investigative Site 018 — Decatur, Georgia, United States
• Forest Investigative Site 022 — Hoffman Estates, Illinois, United States
• Forest Investigative Site 014 — Berlin, New Jersey, United States
• Forest Investigative Site 005 — Cherry Hill, New Jersey, United States
• Forest Investigative Site 015 — Albuquerque, New Mexico, United States
• Forest Investigative Site 028 — Brooklyn, New York, United States
• Forest Investigative Site 010 — Brooklyn, New York, United States
• Forest Investigative Site 002 — Cedarhurst, New York, United States
• Forest Investigative Site 004 — Mount Kisco, New York, United States
• Forest Investigative Site 003 — New York, New York, United States
• Forest Investigative Site 007 — New York, New York, United States

Full record on ClinicalTrials.gov

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