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

Completed · Phase 4 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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).

Key facts

Study ID

NCT02288325

Run by

Forest Laboratories

People needed

644

Starts

2014-11-18

Expected to finish

2016-09-16

Last updated by the study team

2018-10-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Forest Investigative Site 053 — Birmingham, Alabama, United States
• Forest Investigative Site 050 — Dothan, Alabama, United States
• Forest Investigative Site 039 — Phoenix, Arizona, United States
• Forest Investigative Site 048 — Beverly Hills, California, United States
• Forest Investigative Site 047 — Chino, California, United States
• Forest Investigative Site 028 — Costa Mesa, California, United States
• Forest Investigative Site 021 — Encino, California, United States
• Forest Investigative Site 052 — Lemon Grove, California, United States
• Forest Investigative Site 042 — Oceanside, California, United States
• Forest Investigative Site 016 — Sherman Oaks, California, United States
• Forest Investigative Site 037 — Sherman Oaks, California, United States
• Forest Investigative Site 043 — Simi Valley, California, United States
• Forest Investigative Site 040 — Cromwell, Connecticut, United States
• Forest Investigative Site 038 — Norwich, Connecticut, United States
• Forest Investigative Site 023 — Bradenton, Florida, United States
• Forest Investigative Site 018 — Fort Myers, Florida, United States
• Forest Investigative Site 001 — Jacksonville, Florida, United States
• Forest Investigative Site 008 — Jacksonville Beach, Florida, United States
• Forest Investigative Site 057 — Kissimmee, Florida, United States
• Forest Investigative Site 009 — Orlando, Florida, United States
• Forest Investigative Site 045 — West Palm Beach, Florida, United States
• Forest Investigative Site 034 — Alpharetta, Georgia, United States
• Forest Investigative Site 049 — Smyrna, Georgia, United States
• Forest Investigative Site 019 — Schaumburg, Illinois, United States
• Forest Investigative Site 020 — Methuen, Massachusetts, United States

Full record on ClinicalTrials.gov

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