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Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder

Major Depressive Disorder (MDD) 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

Clinical Trial Summary

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.

Clinical Trial Description

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

Patients 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03087916
Study type Interventional
Source Allergan
Contact Allergan, Inc.
Email clinicaltrials@allergan.com
Status Recruiting
Phase Phase 3
Start date June 2015
Completion date March 2018
View Details
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