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

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).

Timeline

Start

2011-06

Primary completion

2012-03

Completion

2012-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Levomilnacipran ER 40 mg; p = 0.0027; Least squares mean difference -3.303 (95% CI -5.457 to -1.148) NCT01377194 ↗

registry analysis (superiority or other test); Placebo vs Levomilnacipran ER 80 mg; p = 0.0043; Least squares mean difference -3.141 (95% CI -5.293 to -0.988) NCT01377194 ↗

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.
• Bakish D, Bose A, Gommoll C, Chen C, Nunez R, Greenberg WM, Liebowitz M, Khan A. Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: a phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci. 2014 Jan;39(1):40-9. doi: 10.1503/jpn.130040.

Drugs

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

Indications