The efficacy of levomilnacipran ER across symptoms of major depressive disorder: a post hoc analysis of 5 randomized, double-blind, placebo-controlled trials.

Abstract

OBJECTIVE:

A post hoc analysis evaluated the effects of levomilnacipran ER on individual symptoms and symptom domains in adults with major depressive disorder (MDD).

METHODS:

Data were pooled from 5 Phase III trials comprising 2598 patients. Effects on depression symptoms were analyzed based on change from baseline in individual Montgomery-Åsberg Depression Rating Scale (MADRS) item scores. A1dditional evaluations included resolution of individual symptoms (defined as a MADRS item score ≤1 at end of treatment) and concurrent resolution of all 10 MADRS items, all MADRS6 subscale items, and all items included in different symptom clusters (Dysphoria, Retardation, Vegetative Symptoms, Anhedonia).

RESULTS:

Significantly greater mean improvements were found on all MADRS items except Reduced Appetite with levomilnacipran ER treatment compared with placebo. Resolution of individual symptoms occurred more frequently with levomilnacipran ER than placebo for each MADRS item (all P<.05), with odds ratios (ORs) ranging from 1.26 to 1.75; resolution of all 10 items was also greater with levomilnacipran ER (OR=1.57; P=.0051). Significant results were found for the MADRS6 subscale (OR=1.73; P<.0001) and each symptom cluster (OR range, 1.39 [Vegetative Symptoms] to 1.84 [Retardation]; all clusters, P<.01).

CONCLUSION:

Adult MDD patients treated with levomilnacipran ER improved across a range of depression symptoms and symptom domains.

• Authors: Roger S McIntyre, Carl Gommoll, Changzheng Chen, Adam Ruth
• Journal: CNS spectrums (CNS Spectr) Vol. 21 Issue 5 Pg. 385-392 (10 2016) ISSN: 1092-8529 [Print] United States
• PMID: 27292817 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antidepressive Agents
• Cyclopropanes
• Delayed-Action Preparations
• Milnacipran

Topics

• Adult
• Anhedonia
• Anorexia (psychology)
• Antidepressive Agents (therapeutic use)
• Clinical Trials, Phase III as Topic
• Cyclopropanes (therapeutic use)
• Delayed-Action Preparations
• Depression (psychology)
• Depressive Disorder, Major (drug therapy, psychology)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Milnacipran
• Randomized Controlled Trials as Topic
• Suicidal Ideation
• Treatment Outcome