A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

• Status: Completed
• Trial end date: 2016-09-16
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).

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

Details

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

Criteria

Inclusion Criteria

• Currently meet the DMS-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for Major Depressive Disorder (MDD)

• The participant must have an ongoing major depressive episode of at least 8 weeks and no more than 18 months

• The participant must have at least 3 lifetime episodes of MDD (including the current episode)

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

• Participants who are considered a suicide risk

• History of non-response to 2 or more antidepressants (after adequate treatment)

• Participants who have a history of meeting DMS-5 criteria for manic, hypomanic, or mixed episode, obsessive-compulsive disorder, schizophrenia or other psychotic disorder

• Panic disorder