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Therapeutic Areas: Psychiatry/Psychology | Neurology | Family Medicine
Disease Category: Depression (Major/Severe)
Location: United States, FL
A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder
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.
CW ID: 212058
Date Last Changed:
February 15, 2017
Key Inclusion Criteria:
Key Psychiatric Exclusion Criteria:
Key Treatment-Related Exclusion Criteria:
Other Key Medical Exclusion Criteria:
Protocol Number: LVM-MD-11
Alexis WolfeUniversity of South Florida- Rothman Center for Pediatric Neuropsychiatry800 6th Street SouthSt. Petersburg, FL 33701Phone: 727-767-8230
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