Safety and Efficacy of Vilazodone in Major Depressive Disorder

Completed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Key facts

Study ID

NCT01473381

Run by

Forest Laboratories

People needed

1162

Starts

2011-12-01

Expected to finish

2013-06-01

Last updated by the study team

2014-08-08

Who can join

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

You may qualify if…

• Men and women, 18-70 years of age.
• Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder.
• The patient's current major depressive episode must be at least 8 weeks and no longer than 12 months in duration.

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 016 — Dothan, Alabama, United States
• Forest Investigative Site 033 — Scottsdale, Arizona, United States
• Forest Investigative Site 027 — Fayetteville, Arkansas, United States
• Forest Investigative Site 029 — Cerritos, California, United States
• Forest Investigative Site 002 — Costa Mesa, California, United States
• Forest Investigative Site 019 — Murrieta, California, United States
• Forest Investigative Site 025 — Oceanside, California, United States
• Forest Investigative Site 043 — Orange, California, United States
• Forest Investigative Site 003 — Redlands, California, United States
• Forest Investigative Site 046 — Sherman Oaks, California, United States
• Forest Investigative Site 057 — Upland, California, United States
• Forest Investigative Site 034 — Cromwell, Connecticut, United States
• Forest Investigative Site 038 — Fort Myers, Florida, United States
• Forest Investigative Site 018 — Gainsville, Florida, United States
• Forest Investigative Site 055 — Hallandale, Florida, United States
• Forest Investigative Site 063 — Jacksonville, Florida, United States
• Forest Investigative Site 035 — Miami, Florida, United States
• Forest Investigative Site 030 — Orlando, Florida, United States
• Forest Investigative Site 062 — Orlando, Florida, United States
• Forest Investigative Site 045 — Pembroke Pines, Florida, United States
• Forest Investigative Site 051 — Tampa, Florida, United States
• Forest Investigative Site 032 — West Palm Beach, Florida, United States
• Forest Investigative Site 022 — Winter Park, Florida, United States
• Forest Investigative Site 060 — Atlanta, Georgia, United States
• Forest Investigative Site 036 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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