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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Vilazodone Hydrochloride

Criteria

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.