Status:
COMPLETED
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Lead Sponsor:
Forest Laboratories
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
1162 Patients enrolled
Trial Details
Trial ID
NCT01473381
Start Date
December 1 2011
End Date
June 1 2013
Last Update
August 8 2014
Active Locations (54)
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1
Forest Investigative Site 036
Birmingham, Alabama, United States, 35216
2
Forest Investigative Site 016
Dothan, Alabama, United States, 36303
3
Forest Investigative Site 033
Scottsdale, Arizona, United States, 85254
4
Forest Investigative Site 027
Fayetteville, Arkansas, United States, 72703