NCT03569475

Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder

A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Levomilnacipran ER	Levomilnacipran extended-release oral capsules
DRUG	Fluoxetine	Fluoxetine oral capsules
DRUG	Placebo	Matching placebo oral capsules

Timeline

• Start date: 2018-07-06
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2018-06-26
• Last updated: 2022-03-25
• Results posted: 2022-03-25

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study