Major Depressive Disorder Clinical Trial
Official title:
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.
Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel
group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be
approximately 10 weeks in duration:
- 1-week screening/washout period
- 8-week double-blind treatment period
- 1-week double-blind down-taper period
Participants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1
of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or
fluoxetine 20 mg/day.
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