Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Levomilnacipran; Milnacipran

Criteria

Inclusion Criteria:

• Men and women, 18-80 years old

• Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

• The patient's current depressive episode must be at least 4 weeks in duration

Exclusion Criteria:

• Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.

• Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.

• Patients who are considered a suicide risk