Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With 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 relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.
Key facts
- Study ID
- NCT02431806
- Run by
- Forest Laboratories
- People needed
- 552
- Starts
- 2015-06-23
- Expected to finish
- 2019-08-19
- Last updated by the study team
- 2020-09-07
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Harmonex, Inc — Dothan, Alabama, United States
- University of Arizona Department of Psychiatry — Tucson, Arizona, United States
- Advanced Research Center, Inc. — Anaheim, California, United States
- ProScience Research Group — Culver City, California, United States
- Sun Valley Research Center — Imperial, California, United States
- Alliance for Research — Long Beach, California, United States
- Asclepes Research Centers — Panorama City, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- Pacific Clinical Research Medical Group — Upland, California, United States
- MCB Clinical Research Center — Colorado Springs, Colorado, United States
- Florida Clinical Research Center; LLC — Bradenton, Florida, United States
- Coastal Clinical Research Specialists — Fernandina Beach, Florida, United States
- Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
- Research in Miami Inc — Hialeah, Florida, United States
- Advanced Research Institute of Miami — Homestead, Florida, United States
- Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
- Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
- Medical Research Group of Central Florida — Orange City, Florida, United States
- Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
- University of South Florida Board of Trustee — Tampa, Florida, United States
- Atlanta Center for Medical Research — Atlanta, Georgia, United States
- Institute for Behavioral Medicine — Smyrna, Georgia, United States
- Clinical Research Institute — Stockbridge, Georgia, United States
- Sandeep Gaonkar, MD — Naperville, Illinois, United States
- NeuroMedical Institute — Panama, Illinois, United States
Full record on ClinicalTrials.gov
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