Safety and Efficacy of Vilazodone in 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