Efficacy and Safety of Levomilnacipran Sustained Release 40 mg, 80 mg, or 120 mg in Major Depressive Disorder: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
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OBJECTIVE: This phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and tolerability of fixed-dose levomilnacipran sustained release (SR) compared with placebo in patients with major depressive disorder (MDD); the study was conducted from September 2009-May 2011. METHOD: Outpatients met DSM-IV-TR criteria for MDD with an ongoing major depressive episode ≥ 8 weeks' duration. After a 1-week placebo lead-in, patients were randomly assigned to receive placebo (n = 179) or levomilnacipran SR 40 mg (n = 181), 80 mg (n = 181), or 120 mg (n = 183) once daily for 8 weeks of double-blind treatment, followed by a 2-week double-blind down-taper. The primary efficacy parameter was change from baseline on the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) total score. The prespecified secondary efficacy parameter was change from baseline in Sheehan Disability Scale (SDS) total score. Additional efficacy measures included the 17-item Hamilton Depression Rating Scale (HDRS(17)) and Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I). Safety and tolerability were also evaluated. RESULTS: The least squares mean difference (LSMD) for change from baseline in MADRS total score was significantly superior to placebo for all dose groups: -3.23 (P = .0186), -3.99 (P = .0038), and -4.86 (P = .0005) for levomilnacipran SR 40, 80, and 120 mg, respectively. The LSMD was significantly different for levomilnacipran SR 80 mg and 120 mg versus placebo on the SDS (-2.51 and -2.57, respectively, P < .05 for both doses), HDRS(17) (-2.09 and -2.34, respectively, P < .05 for both doses), CGI-S (-0.43 [P < .01] and -0.35 [P < .05], respectively), and CGI-I (-0.34 and -0.32, respectively, P < .05 for both doses) assessments. The most common treatment-emergent adverse events (≥ 10% of any treatment group) were headache, nausea, constipation, dry mouth, increased heart rate, and hyperhidrosis. CONCLUSIONS: Levomilnacipran SR demonstrated significant improvement in depressive symptoms and functioning relative to placebo. In this study, levomilnacipran SR was generally well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00969709.
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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 Asnis et al., 2013
The overall safety profile of levomilnacipran ER was consistent with the completed acute and long-term levomilnacipran ER studies.
“The overall safety profile of levomilnacipran ER was consistent with the completed acute (Asnis et al., 2013; Bakish et al., 2014; Gommoll et al., 2014; Montgomery et al., 2013; Sambunaris et al., 2014) and long‐term (Mago et al., 2013) levomilnacipran ER studies”
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 Asnis et al., 2013
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Gonzalez, E. A. (2018) · Springer eBooks · doi:10.1007/978-3-319-57111-9_9266
(2019) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615372997.as03
Gonzalez, E. A. (2017) · Springer eBooks · doi:10.1007/978-3-319-56782-2_9266-1
(2019) · American Psychiatric Association Publishing eBooks · doi:10.1176/appi.books.9781615372300.as03
Huang, T., Zhang, P., Zhou, Y., Wang, L., Zhang, Q., Li, M., & Xiao, J. (2025) · Frontiers in Pharmacology · doi:10.3389/fphar.2025.1719881
Duncan, E., Hersant, H., & Khairova, R. A. (2026) · Springer eBooks · doi:10.1007/978-3-032-15772-0_4
(2014) · Europe PMC (PubMed Central) · Cited by 24 · see citing works
- Authors
- Asnis, G. M., Bose, A., Gommoll, C. P., Chen, C., & Greenberg, W. M.
- Affiliations
- Albert Einstein College of Medicine (US)
- Corresponding author
- Asnis, Gregory M.
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2013-03-15
- Volume
- 74
- Issue
- 03
- Pages
- 242-248
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2061731424
- Cited by
- 83
- References
- 24
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2023: 4 · 2022: 4 · 2021: 2 · 2020: 1 · 2019: 6 · 2018: 3 · 2017: 8 · 2016: 8 · 2015: 15 · 2014: 17 · 2013: 8
- FWCI
- 11.77
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bristol-Myers Squibb
- 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, dose comparison, tolerability, disability, Montgomery-Asberg Depression Rating Scale, Sheehan Disability Scale, clinical global impression, outpatients, fixed-dose dosing, norepinephrine reuptake inhibitors, adverse events, discontinuation
- MeSH terms
- Milnacipran, Adult, Cyclopropanes, Delayed-Action Preparations, Major Depressive Disorder, Depressive Disorder, Major, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Stereoisomerism, Treatment Outcome, Drug Monitoring, Selective Serotonin Reuptake Inhibitors, Diagnostic and Statistical Manual of Mental Disorders
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