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Cited by 78Treatment of Major DepressionAnxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesMental Health Treatment and Access

Efficacy and Safety of Levomilnacipran Sustained Release in Moderate to Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study

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Montgomery, Stuart A., Mansuy, Lucilla, Ruth, Adam, Bose, Anjana, Li, Hua, Li, Dayong·2013·The Journal of Clinical Psychiatry
DOI 10.4088/jcp.12m08141
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Abstract

OBJECTIVE: To investigate the efficacy and safety of levomilnacipran sustained release (SR), an antidepressant candidate in late-stage development, in major depressive disorder (MDD). METHOD: Between December 2006 and October 2007, a 10-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, flexible-dose trial assessed once-daily levomilnacipran SR (75 mg or 100 mg) in outpatients (18-70 years) meeting DSM-IV criteria for a major depressive episode (duration ≥ 1 month) with a 17-item Hamilton Depression Rating Scale (HDRS17) score > 22 and Sheehan Disability Scale (SDS) score ≥ 10. Levomilnacipran SR dose was increased to 100 mg/d over 12 days. The primary efficacy measure was Montgomery Asberg Depression Rating Scale (MADRS) score change from baseline to week 10; secondary efficacy measures were the HDRS17, SDS, Clinical Global Impressions-Improvement scale, and MADRS response (≥ 50% decrease from baseline) and remission (score ≤ 10). Safety was evaluated according to adverse events, laboratory investigations, and vital signs/physical findings. RESULTS: Efficacy analyses included 276 levomilnacipran SR-treated patients and 277 placebo-treated patients. Levomilnacipran SR was significantly superior to placebo on MADRS total score change from baseline to week 10 (least squares mean difference [LSMD] = -4.2 [95% CI, -5.7 to -2.6]; P < .0001). Statistical significance in favor of levomilnacipran SR was demonstrated on change from baseline to week 10 in HDRS17 total score (LSMD = -3.4 [95% CI, -4.7 to -2.2]; P < .0001) and SDS total score (LSMD = -3.4 [95% CI, -4.6 to -2.2]; P < .0001) and subscales. Significantly more levomilnacipran SR patients versus placebo patients achieved MADRS response (59.1% vs 42.2%; P < .0001) and remission (46.4% vs 26.0%; P < .0001). Levomilnacipran SR was generally safe and well tolerated; more levomilnacipran SR patients (9.4%) versus placebo patients (6.5%) discontinued due to adverse events, but more placebo patients versus levomilnacipran SR patients discontinued overall (24.9% vs 20.2%). CONCLUSIONS: Levomilnacipran SR demonstrated robust efficacy on all measures and was generally well tolerated. TRIAL REGISTRATION: EudraCT number: 2006-002404-34

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  • Four of these trials demonstrated statistically significant improvements versus placebo in the primary efficacy endpoint, change from baseline in MADRS total score.

    “Four of these trials demonstrated statistically significant improvements versus placebo in the primary efficacy endpoint, change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS; Montgomery & Asberg, 1979) total score (Asnis et al., 2013; Bakish et al., 2014; Montgomery et al., 2013; Sambunaris et al., 2014), while one study had numerically greater improvement with levomilnacipran”

    From Relapse prevention with levomilnacipran ER in adults with major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled study (2019) · cites this paper as Montgomery et al., 2013

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  1. P u b M e d 5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000.

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Authors
Montgomery, S. A., Mansuy, L., Ruth, A., Bose, A., Li, H., & Li, D.
Affiliations
University of London (GB)
Corresponding author
Montgomery, Stuart A.
ORCID
Venue
The Journal of Clinical Psychiatry
Publisher
Physicians Postgraduate Press, Inc
Published
2013-04-15
Volume
74
Issue
04
Pages
363-369
ISSN
0160-6689 (ISSN-L)
DOI
10.4088/jcp.12m08141
OpenAlex
W2001014758
Cited by
78
References
31
Citations by year
2026: 1 · 2025: 4 · 2024: 2 · 2023: 4 · 2022: 4 · 2021: 2 · 2020: 3 · 2019: 5 · 2018: 3 · 2017: 6 · 2016: 7 · 2015: 14 · 2014: 14 · 2013: 9
FWCI
10.77
Type
journal article
Language
en
Open access
Locations
  • The Journal of Clinical Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Les Laboratories Pierre Fabre
  • Institut National de la Santé et de la Recherche Médicale
  • European College of Neuropsychopharmacology
  • National Institutes of Health
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
major depressive disorder, antidepressant efficacy, antidepressant safety, serotonin reuptake inhibitors, depression remission, functional disability, adverse events, outpatients, dose escalation, Sheehan Disability Scale, late-stage drug development
MeSH terms
Milnacipran, Adolescent, Adult, Aged, Antidepressive Agents, Cyclopropanes, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Young Adult

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