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Cited by 70Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesMental Health Treatment and Access

Levomilnacipran ER 40 mg and 80 mg in patients with major depressive disorder: A phase III, randomized, double-blind, fixed-dose, placebo-controlled study

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Bakish, David, Bose, Anjana, Gommoll, Carl, Chen, Changzheng, Nunez, Rene, Greenberg, William M., Liebowitz, Michael, Khan, Arif·2014·Journal of Psychiatry and Neuroscience
DOI 10.1503/jpn.130040PMC PMC3868664
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Abstract

BACKGROUND: Major depressive disorder (MDD) is a global health concern. This study examined the efficacy, safety and tolerability of an extended-release (ER) formulation of levomilnacipran, an antidepressant approved for the treatment of MDD in adults. METHODS: This 10-week (1-week placebo run-in period, 8-week double-blind treatment, 1-week down-taper), multicentre, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted between June 2011 and March 2012. Adult outpatients (age 18-75 yr) with MDD were randomly assigned (1:1:1) to placebo or to levomilnacipran ER 40 mg/day or 80 mg/day. For primary efficacy, we analyzed the Montgomery-Åsberg Depression Rating Scale (MADRS) change from baseline to week 8 using a mixed-effects model for repeated-measures approach on the intent-to-treat (ITT) population. For secondary efficacy, we used the Sheehan Disability Scale (SDS), and for safety, we examined adverse events and laboratory, vital sign/physical and electrocardiography findings. RESULTS: The ITT population consisted of 185 patients in the placebo group, 185 in the levomilnacipran ER 40 mg/day group and 187 in the levomilnacipran ER 80 mg/day group. Study completion rates were similar among the groups (76%-83%). On MADRS change from baseline the least squares mean difference (LSMD) and 95% confidence interval (CI) versus placebo was significant for levomilnacipran ER 40 mg/day (-3.3 [-5.5 to -1.1], p = 0.003) and 80 mg/day (-3.1, [-5.3 to -1.0], p = 0.004). On SDS change from baseline the LSMD (and 95% CI) versus placebo was also significant for levomilnacipran ER 40 mg/day (-1.8, 95% [-3.6 to 0], p = 0.046) and 80 mg/day (-2.7 [-4.5 to -0.9], p = 0.003). More patients in the levomilnacipran ER than the placebo group prematurely exited the study owing to adverse events; common adverse events (≥ 5% and ≥ double the rate of placebo) were nausea, dry mouth, increased heart rate, constipation, dizziness, hyperhidrosis, urinary hesitation and erectile dysfunction. LIMITATIONS: Limitations to our study included short treatment duration and lack of an active control arm. CONCLUSION: Levomilnacipran ER at doses of 40 mg/day and 80 mg/day demonstrated efficacy on symptomatic and functional measures of MDD and was generally well tolerated in this patient population. CLINICAL TRIAL REGISTRATION: NCT01377194.

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  1. [10]American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington (DC): American Psychiatric Association; 2000. Text rev. [Google Scholar]

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Authors
Bakish, D., Bose, A., Gommoll, C., Chen, C., Nunez, R., Greenberg, W. M., Liebowitz, M., & Khan, A.
Affiliations
  • Duke University (US)
  • Forest Research Institute, Jersey City, NJ, USA
ORCID
Venue
Journal of Psychiatry and Neuroscience
Publisher
Canadian Science Publishing
Published
2014-01
Volume
39
Issue
1
Pages
40-49
ISSN
  • 1180-4882 (ISSN-L)
  • 1488-2434
DOI
10.1503/jpn.130040
PMC
PMC3868664
OpenAlex
W2046440231
Cited by
70
References
29
Citations by year
2026: 1 · 2025: 3 · 2024: 3 · 2023: 4 · 2022: 2 · 2021: 2 · 2020: 2 · 2019: 6 · 2018: 2 · 2017: 8 · 2016: 9 · 2015: 12 · 2014: 11 · 2013: 5
FWCI
9.69
Type
journal article
Language
en
Open access
Licence
www.nrcresearchpress.com/page/about/CorporateTextAndDataMining (tdm)
Locations
  • Journal of Psychiatry and Neuroscience (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
Keywords
levomilnacipran, major depressive disorder, sustained-release formulation, antidepressant efficacy, adverse events, tolerability, serotonin reuptake inhibitors, dose comparison, Montgomery-Asberg Depression Rating Scale, Sheehan Disability Scale, outpatients, laboratory findings, vital signs, discontinuation rate, treatment-emergent adverse events
MeSH terms
Milnacipran, Adolescent, Adult, Aged, Antidepressive Agents, Cyclopropanes, Major Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Treatment Outcome, Young Adult

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