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

NCT01034462

Run by

Forest Laboratories

People needed

442

Starts

2009-12-01

Expected to finish

2011-12-01

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: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
• Patients who are considered a suicide risk

Where it is running

• Forest Investigative Site 055 — Dothan, Alabama, United States
• Forest Investigative Site 065 — Highlands Ranch, Colorado, United States
• Forest Investigative Site 057 — Boca Raton, Florida, United States
• Forest Investigative Site 060 — Boca Raton, Florida, United States
• Forest Investigative Site 064 — Gainesville, Florida, United States
• Forest Investigative Site 053 — Ocala, Florida, United States
• Forest Investigative Site 061 — Orlando, Florida, United States
• Forest Investigative Site 059 — Winter Park, Florida, United States
• Forest Investigative Site 070 — Atlanta, Georgia, United States
• Forest Investigative Site 066 — Smyrna, Georgia, United States
• Forest Investigative Site 072 — Chicago, Illinois, United States
• Forest Investigative Site 050 — Oak Brook, Illinois, United States
• Forest Investigative Site 063 — Indianapolis, Indiana, United States
• Forest Investigative Site 071 — Prairie Village, Kansas, United States
• Forest Investigative Site 052 — Shreveport, Louisiana, United States
• Forest Investigative Site 051 — Brooklyn, New York, United States
• Forest Investigative Site 056 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 067 — Oklahoma City, Oklahoma, United States
• Forest Investigative Site 058 — Salem, Oregon, United States
• Forest Investigative Site 054 — Allentown, Pennsylvania, United States
• Forest Investigative Site 062 — San Antonio, Texas, United States
• Forest Investigative Site 068 — Virginia Beach, Virginia, United States
• Forest Investigative Site 069 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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