NCT00969709

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 724 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Levomilnacipran ER	Levomilnacipran ER, 40 mg, oral administration, in capsule form, once daily for 8 weeks.
DRUG	Levomilnacipran ER	Levomilnacipran ER, 80 mg, oral administration, in capsule form, once daily for 8 weeks.
DRUG	Levomilnacipran ER	Levomilnacipran ER, 120 mg, oral administration, in capsule form, once daily for 8 weeks.
DRUG	Placebo	Matching placebo capsules, oral administration, once daily for 8 weeks.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-05-01
• First posted: 2009-09-01
• Last updated: 2013-10-25
• Results posted: 2013-10-25

Locations

38 sites across 1 country: United States