Safety, Efficacy, and Tolerability of Vilazodone in Major Depressive Disorder

A Double-blind, Placebo-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder

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.

Inclusion Criteria:

• 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 Criteria:

• 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.