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

• Published in: CNS spectrums 2015-04, Vol.20 (2), p.148-156
• Main Authors: Montgomery, Stuart A., Gommoll, Carl P., Chen, Changzheng, Greenberg, William M.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antidepressants; Antidepressive Agents - administration & dosage; Antidepressive Agents - therapeutic use; Anxiety disorders; Clinical outcomes; Cyclopropanes - administration & dosage; Cyclopropanes - therapeutic use; Delayed-Action Preparations; Depressive Disorder, Major - drug therapy; Depressive Disorder, Major - psychology; Double-Blind Method; Double-blind studies; Fear & phobias; Female; Humans; Illnesses; Male; Mental depression; Middle Aged; Milnacipran; Original Research; Patients; Population; Post traumatic stress disorder; Remission (Medicine); Serotonin; Treatment Outcome; Young Adult
• ISSN: 1092-8529; 2165-6509
• DOI: 10.1017/S1092852914000273

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.