Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Depression, Major Depressive Disorder

In brief

The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Key facts

Study ID

NCT01085812

Run by

Forest Laboratories

People needed

734

Starts

2010-03-01

Expected to finish

2011-10-01

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, 18-65 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

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
• 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

Where it is running

• Forest Investigative Site #023 — Beverly Hills, California, United States
• Forest Investigative Site #017 — Encino, California, United States
• Forest Investigative Site #021 — Garden Grove, California, United States
• Forest Investigative Site #025 — Newport Beach, California, United States
• Forest Investigative Site #030 — Orange, California, United States
• Forest Investigative Site #002 — San Diego, California, United States
• Forest Investigative Site #003 — Sherman Oaks, California, United States
• Forest Research Institute #001 — Bonita Springs, Florida, United States
• Forest Investigative Site #015 — Fort Myers, Florida, United States
• Forest Investigative Site #029 — Maitland, Florida, United States
• Forest Investigative Site #005 — North Miami, Florida, United States
• Forest Investigative Site #016 — Orlando, Florida, United States
• Forest Investigative Site #004 — South Miami, Florida, United States
• Forest Investigative Site #014 — Atlanta, Georgia, United States
• Forest Investigative Site #022 — Chicago, Illinois, United States
• Forest Investigative Site #006 — Chicago, Illinois, United States
• Forest Investigative Site #009 — Prairie Village, Kansas, United States
• Forest Investigative Site #013 — Baltimore, Maryland, United States
• Forest Investigative Site #010 — Boston, Massachusetts, United States
• Forest Investigative Site #012 — St Louis, Missouri, United States
• Forest Investigative Site #011 — Staten Island, New York, United States
• Forest Investigative Site #026 — Portland, Oregon, United States
• Forest Investigative Site #008 — Bridgeville, Pennsylvania, United States
• Forest Investigative Site #028 — Norristown, Pennsylvania, United States
• Forest Investigative Site #020 — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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