Status:
COMPLETED
Safety, Efficacy, and Tolerability 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 further characterize the efficacy, safety, and tolerability of a single fixed dose level 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 :
February 1 2013
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT01473394
Start Date
December 1 2011
End Date
February 1 2013
Last Update
April 3 2014
Active Locations (14)
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1
Forest Investigative Site 009
Beverly Hills, California, United States, 90210
2
Forest Investigative Site 003
Encino, California, United States, 91316
3
Forest Investigative Site 010
New Port Beach, California, United States, 92660
4
Forest Investigative Site 005
Jacksonville, Florida, United States, 32216