Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).

Key facts

Study ID

NCT01254305

Run by

Forest Laboratories

People needed

262

Starts

2011-04-01

Expected to finish

2012-07-01

Last updated by the study team

2014-08-06

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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (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 of child-bearing 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 010 — Birmingham, Alabama, United States
• Forest Investigative Site 002 — Little Rock, Arkansas, United States
• Forest Investigative Site 001 — Cerritos, California, United States
• Forest Investigative Site 014 — Fort Myers, Florida, United States
• Forest Investigative Site 006 — Jacksonville, Florida, United States
• Forest Investigative Site 017 — Orange City, Florida, United States
• Forest Investigative Site 005 — Orlando, Florida, United States
• Forest Investigative Site 012 — Tampa, Florida, United States
• Forest Investigative Site 009 — Atlanta, Georgia, United States
• Forest Investigative Site 016 — Joliet, Illinois, United States
• Forest Investigative Site 004 — New Orleans, Louisiana, United States
• Forest Investigative Site 022 — Boston, Massachusetts, United States
• Forest Investigative Site 015 — Cedarhurst, New York, United States
• Forest Investigative Site 011 — The Bronx, New York, United States
• Forest Investigative Site 003 — Cincinnati, Ohio, United States
• Forest Investigative Site 013 — Dayton, Ohio, United States
• Forest Investigative Site 020 — Lincoln, Rhode Island, United States
• Forest Investigative Site 018 — Memphis, Tennessee, United States
• Forest Investigative Site 008 — Dallas, Texas, United States
• Forest Investigative Site 007 — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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