Safety, Efficacy and Tolerability of Vilazodone in Patients With 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

NCT01766401

Run by

Forest Laboratories

People needed

402

Starts

2013-01-31

Expected to finish

2014-01-29

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
• Patients with a history of meeting DSM-IV-TR criteria for:
• any manic, 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 cognitive disorders
• Patients who are considered a suicide risk

Where it is running

• Forest Investigative Site 022 — Arcadia, California, United States
• Forest Investigative Site 023 — Beverly Hills, California, United States
• Forest Investigative Site 010 — Encino, California, United States
• Forest Investigative Site 025 — Newport Beach, California, United States
• Forest Investigative Site 004 — Redlands, California, United States
• Forest Investigative Site 007 — Sherman Oaks, California, United States
• Forest Investigative Site 016 — Temecula, California, United States
• Forest Investigative Site 012 — Upland, California, United States
• Forest Investigative Site 017 — Coral Springs, Florida, United States
• Forest Investigative Site 028 — Fort Myers, Florida, United States
• Forest Investigative Site 002 — Jacksonville, Florida, United States
• Forest Investigative Site 020 — Leesburg, Florida, United States
• Forest Investigative Site 024 — Miami, Florida, United States
• Forest Investigative Site 001 — Orlando, Florida, United States
• Forest Investigative Site 026 — Indianapolis, Indiana, United States
• Forest Investigative Site 029 — Shreveport, Louisiana, United States
• Forest Investigative Site 019 — Las Vegas, Nevada, United States
• Forest Investigative Site 003 — Canton, Ohio, United States
• Forest Investigative Site 031 — Columbus, Ohio, United States
• Forest Investigative Site 021 — Mason, Ohio, United States
• Forest Investigative Site 030 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 005 — Salem, Oregon, United States
• Forest Investigative Site 014 — Allentown, Pennsylvania, United States
• Forest Investigative Site 015 — Philadelphia, Pennsylvania, United States
• Forest Investigative Site 027 — Lincoln, Rhode Island, United States

Full record on ClinicalTrials.gov

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