Safety, Efficacy and Tolerability of Vilazodone in 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

NCT01629966

Run by

Forest Laboratories

People needed

680

Starts

2012-06-30

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 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)

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 001 — Birmingham, Alabama, United States
• Forest Investigative Site 021 — Beverly Hills, California, United States
• Forest Investigative Site 023 — Glendale, California, United States
• Forest Investigative Site 011 — Paramount, California, United States
• Forest Investigative Site 026 — Norwich, Connecticut, United States
• Forest Investigative Site 027 — Waterbury, Connecticut, United States
• Forest Investigative Site 005 — Delray Beach, Florida, United States
• Forest Investigative Site 014 — Oakland Park, Florida, United States
• Forest Investigative Site 019 — South Miami, Florida, United States
• Forest Investigative Site 038 — Atlanta, Georgia, United States
• Forest Investigative Site 035 — Decatur, Georgia, United States
• Forest Investigative Site 028 — Chicago, Illinois, United States
• Forest Investigative Site 030 — Schaumburg, Illinois, United States
• Forest Investigative Site 029 — Topeka, Kansas, United States
• Forest Investigative Site 033 — Wichita, Kansas, United States
• Forest Investigative Site 010 — Lake Charles, Louisiana, United States
• Forest Investigative Site 031 — Baltimore, Maryland, United States
• Forest Investigative Site 025 — Boston, Massachusetts, United States
• Forest Investigative Site 037 — St Louis, Missouri, United States
• Forest Investigative Site 015 — Las Vegas, Nevada, United States
• Forest Investigative Site 016 — Berlin, New Jersey, United States
• Forest Investigative Site 007 — Brooklyn, New York, United States
• Forest Investigative Site 024 — New York, New York, United States
• Forest Investigative Site 032 — New York, New York, United States
• Forest Investigative Site 012 — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.