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

• Status: Completed
• Trial end date: 1969-12-31
• 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:

• any manic or hypomanic episode

• schizophrenia or any other psychotic disorder

• obsessive-compulsive disorder

• Patients who are considered a suicide risk