NCT01034462

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

A Double-blind, Placebo-Controlled, Flexible-Dose Study of F2695 SR in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Levomilnacipran ER	Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. 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: 2009-12-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-12-17
• Last updated: 2013-10-25
• Results posted: 2013-10-25

Locations

23 sites across 1 country: United States