NCT02288325

A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With Levomilnacipran ER in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy, safety and tolerability of levomilnacipran extended-release (ER) compared with placebo in the prevention of depression relapse in major depressive disorder (MDD).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Levomilnacipran ER	Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
DRUG	Placebo	Dose-matched placebo taken orally once daily.

Timeline

• Start date: 2014-11-18
• Primary completion: 2016-09-16
• Completion: 2016-09-16
• First posted: 2014-11-11
• Last updated: 2018-10-29
• Results posted: 2018-10-29

Locations

47 sites across 1 country: United States