Safety and Efficacy of Levomilnacipran ER (Levomilnacipran 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 compared to placebo in patients with Major Depressive Disorder (MDD).

Key facts

Study ID

NCT01377194

Run by

Forest Laboratories

People needed

568

Starts

2011-06-01

Expected to finish

2012-03-01

Last updated by the study team

2013-10-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women, 18-75 years old
• Currently meet the DSM-IV-TR criteria for Major Depressive Disorder
• The patient's current depressive episode must be at least 6 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 who are considered a suicide risk
• 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.

Where it is running

• Forest Investigative Site 037 — Beverly Hills, California, United States
• Forest Investigative Site 012 — Encino, California, United States
• Forest Investigative Site 038 — Newport Beach, California, United States
• Forest Investigative Site 024 — Oceanside, California, United States
• Forest Investigative Site 001 — Redlands, California, United States
• Forest Investigative Site 031 — San Diego, California, United States
• Forest Investigative Site 050 — Sherman Oaks, California, United States
• Forest Investigative Site 034 — Cromwell, Connecticut, United States
• Forest Investigative Site 021 — Coral Springs, Florida, United States
• Forest Investigative Site 043 — Fort Myers, Florida, United States
• Forest Investigative Site 018 — Gainesville, Florida, United States
• Forest Investigative Site 060 — Hallandale, Florida, United States
• Forest Investigative Site 020 — Jacksonville, Florida, United States
• Forest Investigative Site 005 — Ocala, Florida, United States
• Forest Investigative Site 014 — Orlando, Florida, United States
• Forest Investigative Site 028 — Orlando, Florida, United States
• Forest Investigative Site 046 — Atlanta, Georgia, United States
• Forest Investigative Site 041 — Chicago, Illinois, United States
• Forest Investigative Site 054 — Chicago, Illinois, United States
• Forest Investigative Site 026 — Hoffman Estates, Illinois, United States
• Forest Investigative Site 045 — Indianapolis, Indiana, United States
• Forest Investigative Site 056 — Prairie Village, Kansas, United States
• Forest Investigative Site 049 — Haverhill, Massachusetts, United States
• Forest Investigative Site 044 — Cherry Hill, New Jersey, United States
• Forest Investigative Site 039 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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