title: Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials.
abstract: OBJECTIVE
  Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD).
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Levomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18-78, with varying histories and symptom severity.
authors.affiliation: 1Imperial College School of Medicine,University of London,London,UK.
authors.forename: Stuart A
authors.initials: SA
authors.lastname: Montgomery
authors.affiliation: 2Clinical Development,Forest Research Institute,Jersey City,New Jersey,USA.
authors.forename: Carl P
authors.initials: CP
authors.lastname: Gommoll
authors.affiliation: 3Biostatistics,Forest Research Institute,Jersey City,New Jersey,USA.
authors.forename: Changzheng
authors.initials: C
authors.lastname: Chen
authors.affiliation: 2Clinical Development,Forest Research Institute,Jersey City,New Jersey,USA.
authors.forename: William M
authors.initials: WM
authors.lastname: Greenberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D003521:Cyclopropanes / Q000008:administration & dosage* / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000078764:Milnacipran; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D003521:Cyclopropanes; D003692:Delayed-Action Preparations; D000078764:Milnacipran
keywords: remission