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

Completed · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00969150

Run by

Forest Laboratories

People needed

362

Starts

2009-09-01

Last updated by the study team

2013-10-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 — Scottsdale, Arizona, United States
• Forest Investigative Site — Encino, California, United States
• Forest Investigative Site — Los Alamitos, California, United States
• Forest Investigative Site — Oceanside, California, United States
• Forest Investigative Site — Denver, Colorado, United States
• Forest Investigative Site — Denver, Colorado, United States
• Forest Investigative Site — Jacksonville, Florida, United States
• Forest Investigative Site — Orlando, Florida, United States
• Forest Investigative Site — Chicago, Illinois, United States
• Forest Investigative Site — Wichita, Kansas, United States
• Forest Investigative Site — Glen Burnie, Maryland, United States
• Forest Investigative Site — Fall River, Massachusetts, United States
• Forest Investigative Site — East Lansing, Michigan, United States
• Forest Investigative Site — Cherry Hill, New Jersey, United States
• Forest Investigative Site — Brooklyn, New York, United States
• Forest Investigative Site — New York, New York, United States
• Forest Investigative Site — Staten Island, New York, United States
• Forest Investigative Site 013 — Canton, Ohio, United States
• Forest Investigative Site — Dayton, Ohio, United States
• Forest Investigative Site — Portland, Oregon, United States
• Forest Investigative Site — Philadelphia, Pennsylvania, United States
• Forest Investigative Site — Lincoln, Rhode Island, United States
• Forest Investigative Site — Woodstock, Vermont, United States
• Forest Investigative Site — Bellevue, Washington, United States
• Forest Investigative Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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