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

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.

Timeline

Start

2009-09

Primary completion

2011-05

Completion

—

Outcome

Met primary endpoint

registry Placebo vs Levomilnacipran ER 40 mg; p = 0.0186; Least squares mean difference -3.23 (95% CI -5.92 to -0.54); Mixed Models Analysis NCT00969709 ↗

registry Placebo vs Levomilnacipran ER 80 mg; p = 0.0038; Least squares mean difference -3.99 (95% CI -6.69 to -1.29); Mixed Models Analysis NCT00969709 ↗

registry Placebo vs Levomilnacipran ER 120 mg; p = 0.0005; Least squares mean difference -4.86 (95% CI -7.59 to -2.12); Mixed Models Analysis NCT00969709 ↗

Publications

• Cutler AJ, Gommoll CP, Chen C, Greenberg WM, Ruth A. Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories. Prim Care Companion CNS Disord. 2015 Jun 11;17(3):10.4088/PCC.14m01753. doi: 10.4088/PCC.14m01753. eCollection 2015.
• Blum SI, Tourkodimitris S, Ruth A. Evaluation of functional health and well-being in patients receiving levomilnacipran ER for the treatment of major depressive disorder. J Affect Disord. 2015 Jan 1;170:230-6. doi: 10.1016/j.jad.2014.09.005. Epub 2014 Sep 10.
• Asnis GM, Bose A, Gommoll CP, Chen C, Greenberg WM. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Mar;74(3):242-8. doi: 10.4088/JCP.12m08197.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levomilnacipran	Small molecule	40 mg	Oral
Subject	Levomilnacipran	Small molecule	80 mg	Oral
Subject	Levomilnacipran	Small molecule	120 mg	Oral

Indications