NCT01377194

Safety and Efficacy of Levomilnacipran ER (Levomilnacipran SR) in Major Depressive Disorder

A Double-blind, Placebo-Controlled, Fixed-Dose Study of Levomilnacipran SR in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER compared to placebo in patients with Major Depressive Disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Levomilnacipran ER	Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
DRUG	Levomilnacipran ER	Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
DRUG	Placebo	Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-06-21
• Last updated: 2013-10-29
• Results posted: 2013-10-29

Locations

51 sites across 2 countries: United States, Canada