NCT02431806

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

A Double-blind, Placebo- and Active-Controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Adolescent Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.
DRUG	Levomilnacipran	Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
DRUG	Fluoxetine	Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.

Timeline

• Start date: 2015-06-23
• Primary completion: 2019-08-19
• Completion: 2019-08-19
• First posted: 2015-05-01
• Last updated: 2020-09-07
• Results posted: 2020-09-07

Locations

49 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study