Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials.

Stuart A Montgomery,Carl P Gommoll,Changzheng Chen,William M Greenberg

doi:10.1017/s1092852914000273

Stuart A Montgomery, Carl P Gommoll + Show 2 more

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https://doi.org/10.1017/s1092852914000273

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Journal: CNS spectrums	Publication Date: Jun 5, 2014
Citations: 23	License type: CC BY 3.0

Affiliation: Imperial College London, University of London

Abstract

Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD). Data were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD duration, recurrence of MDD, current episode duration, number of prior episodes, and baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score. Efficacy was evaluated by MADRS least squares (LS) mean change from baseline, response (MADRS improvement ≥50%), and remission (MADRS ≤10). In the pooled population, treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score (-15.8 versus -12.9; LS mean difference, -2.9; P < .001) and higher response rates (44.7% versus 34.5%; P < .001). Comparable treatment effects were found in most subgroups. Remission rates in the overall population were higher for levomilnacipran ER versus placebo (27.7% versus 21.5%; P < .05); notably high remission rates were seen in patients with baseline MADRS score < 30 (48.8% versus 28.9%; P < .001). Discussion Clinically meaningful improvements in depressive symptoms were found across subgroups, including statistically significant outcomes for both response and remission. Levomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18-78, with varying histories and symptom severity.

Highlights

Patients with major depressive disorder (MDD) are a heterogeneous population, with different symptoms and varying degrees of disease severity
Treatment outcomes can vary significantly based on patient characteristics: for example, male sex, older age, longer duration of illness, more chronic depression, greater number of prior episodes, and more severe depression at baseline have been associated with lower antidepressant efficacy and/or worse treatment outcomes.[9,10,14,18,19,20,21]
The primary results from the individual studies were supported by post hoc analyses conducted in the overall pooled population and in subgroups of patients stratified by sex, age, MDD duration, recurrent MDD, duration of current episode, number of prior episodes, and baseline Clinician-Rated Montgomery–Asberg Depression Rating Scale (MADRS) total score

Summary

Introduction

Patients with major depressive disorder (MDD) are a heterogeneous population, with different symptoms and varying degrees of disease severity. Treatment outcomes can vary significantly based on patient characteristics: for example, male sex, older age, longer duration of illness, more chronic depression, greater number of prior episodes, and more severe depression at baseline have been associated with lower antidepressant efficacy and/or worse treatment outcomes.[9,10,14,18,19,20,21]

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