NCT01085812

Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 734 (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 safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).

Detailed description

Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with Levomilnacipran ER are randomized to continue Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of additional treatment.

Conditions

• Depression
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Levomilnacipran ER	Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
DRUG	Placebo	Matching placebo to be given orally, in capsule form, once daily.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-03-12
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

35 sites across 2 countries: United States, Canada