Francesco Bartoli, Daniele Cavaleri, Ilaria Riboldi, Tommaso Callovini, Cristina Crocamo, Chiara Gastaldon, Andrea Aguglia, Camilla Callegari, Simone Cavallotti, Stefania Chiappini, Marco Cruciata, Armando D'Agostino, Irene Espa, Luigi Grassi, Marta Ielmini, Silvia Mammarella, Giovanni Martinotti, Marianna Rania, Alessandro Rodolico, Rita Roncone, Valentina Roselli, Cristina Segura-Garcia, Maria Salvina Signorelli, Lorenzo Tarsitani, Giovanni Ostuzzi, Giuseppe Carrà
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This study aimed to investigate whether vortioxetine is superior to SSRIs in terms of efficacy and tolerability in older people with moderate-to-severe depression.</p><p><strong>Methods: </strong>The Vortioxetine in the Elderly versus SSRIs: a Pragmatic Assessment (VESPA) study was an assessor-blinded, randomized, parallel-group, superiority trial, comparing flexible doses of vortioxetine versus SSRIs in older adults with depression. This is a post-hoc analysis that excluded participants with milder symptoms of depression. The primary outcome was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Secondary outcomes included clinical response (MADRS total score reduction of ≥ 50%), remission (a MADRS score < 10), and discontinuation rates. Clinical measures were conducted at baseline and at 1-month, 3-month, and 6-month (endpoint) visits.</p><p><strong>Results: </strong>In total, 302 individuals (mean age: 73.4 ± 5.9 years; 68.9% females), comprising 152 randomized to vortioxetine and 150 to SSRIs (sertraline N = 92; paroxetine N = 19; escitalopram N = 19; citalopram N = 16; fluoxetine N = 3; fluvoxamine N = 1), were included in this post-hoc analysis. No significant differences in MADRS improvement between vortioxetine and SSRIs were observed at any follow-up visits and 6-month endpoint (-11.8 ± 10.6 versus -14.0 ± 11.6; p = 0.12). This was further confirmed by a subgroup analysis excluding drug discontinuers (-16.8 ± 9.0 versus -17.6 ± 10.3; p = 0.51). 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Additional trials, possibly based on fixed doses of vortioxetine, are needed.</p><p><strong>Registration: </strong>Clinicaltrials.gov: NCT03779789, registered on 12 Dec 2018; EudraCT number: 2018-001444-66.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":" ","pages":"771-780"},"PeriodicalIF":3.8000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12313815/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Tolerability of Vortioxetine Versus Selective Serotonin Reuptake Inhibitors for Late-Life Depression: A Post-hoc Analysis of the VESPA Study.\",\"authors\":\"Francesco Bartoli, Daniele Cavaleri, Ilaria Riboldi, Tommaso Callovini, Cristina Crocamo, Chiara Gastaldon, Andrea Aguglia, Camilla Callegari, Simone Cavallotti, Stefania Chiappini, Marco Cruciata, Armando D'Agostino, Irene Espa, Luigi Grassi, Marta Ielmini, Silvia Mammarella, Giovanni Martinotti, Marianna Rania, Alessandro Rodolico, Rita Roncone, Valentina Roselli, Cristina Segura-Garcia, Maria Salvina Signorelli, Lorenzo Tarsitani, Giovanni Ostuzzi, Giuseppe Carrà\",\"doi\":\"10.1007/s40266-025-01231-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objectives: </strong>Usual treatment approaches for late-life depression primarily involve selective serotonin reuptake inhibitors (SSRIs). 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引用次数: 0
摘要
背景和目的：通常治疗老年抑郁症的方法主要包括选择性血清素再摄取抑制剂（SSRIs）。最近，沃替西汀的潜在作用引起了人们的注意。本研究旨在探讨沃替西汀在中重度老年抑郁症患者的疗效和耐受性方面是否优于SSRIs。方法：老年人沃替西汀与SSRIs：一项实用评估（VESPA）研究是一项评估盲、随机、平行组、优势试验，比较灵活剂量的沃替西汀与SSRIs在老年抑郁症患者中的作用。这是一项事后分析，排除了抑郁症状较轻的参与者。主要结果是Montgomery-Åsberg抑郁评定量表（MADRS）得分的变化。次要结局包括临床缓解（MADRS总分降低≥50%）、缓解（MADRS评分）。结果：共302例患者(平均年龄：73.4±5.9岁；68.9%女性)，其中152人随机分到沃替西汀组，150人随机分到SSRIs组(舍曲林N = 92；帕罗西汀N = 19；艾司西酞普兰N = 19；西酞普兰N = 16；氟西汀N = 3；氟伏沙明N = 1)，纳入事后分析。沃替西汀和SSRIs在MADRS改善方面在任何随访和6个月终点均未观察到显著差异(-11.8±10.6 vs -14.0±11.6；p = 0.12)。排除停药者的亚组分析进一步证实了这一点(-16.8±9.0 vs -17.6±10.3；p = 0.51)。此外，接受沃替西汀治疗的患者并没有表现出更好的应答率(44.1% vs 53.0%；P = 0.11)，缓解(25.7% vs 34.7%；P = 0.09)和停药(38.0% vs 30.2%；p = 0.17)，包括因副作用或无效而停药，与接受SSRIs治疗的患者相比。结论：沃替西汀在中重度老年抑郁症患者的疗效和耐受性方面并不优于SSRIs。需要更多的试验，可能是基于固定剂量的沃替西汀。注册：Clinicaltrials.gov: NCT03779789，注册于2018年12月12日；稿号：2018-001444-66。
Efficacy and Tolerability of Vortioxetine Versus Selective Serotonin Reuptake Inhibitors for Late-Life Depression: A Post-hoc Analysis of the VESPA Study.
Background and objectives: Usual treatment approaches for late-life depression primarily involve selective serotonin reuptake inhibitors (SSRIs). Recently, the potential role of vortioxetine has garnered attention. This study aimed to investigate whether vortioxetine is superior to SSRIs in terms of efficacy and tolerability in older people with moderate-to-severe depression.
Methods: The Vortioxetine in the Elderly versus SSRIs: a Pragmatic Assessment (VESPA) study was an assessor-blinded, randomized, parallel-group, superiority trial, comparing flexible doses of vortioxetine versus SSRIs in older adults with depression. This is a post-hoc analysis that excluded participants with milder symptoms of depression. The primary outcome was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Secondary outcomes included clinical response (MADRS total score reduction of ≥ 50%), remission (a MADRS score < 10), and discontinuation rates. Clinical measures were conducted at baseline and at 1-month, 3-month, and 6-month (endpoint) visits.
Results: In total, 302 individuals (mean age: 73.4 ± 5.9 years; 68.9% females), comprising 152 randomized to vortioxetine and 150 to SSRIs (sertraline N = 92; paroxetine N = 19; escitalopram N = 19; citalopram N = 16; fluoxetine N = 3; fluvoxamine N = 1), were included in this post-hoc analysis. No significant differences in MADRS improvement between vortioxetine and SSRIs were observed at any follow-up visits and 6-month endpoint (-11.8 ± 10.6 versus -14.0 ± 11.6; p = 0.12). This was further confirmed by a subgroup analysis excluding drug discontinuers (-16.8 ± 9.0 versus -17.6 ± 10.3; p = 0.51). In addition, people treated with vortioxetine did not exhibit better rates of response (44.1 versus 53.0%; p = 0.11), remission (25.7 versus 34.7%; p = 0.09), and discontinuation (38.0 versus 30.2%; p = 0.17), including discontinuation owing to either side effects or inefficacy, compared with those treated with SSRIs.
Conclusions: Vortioxetine was not superior to SSRIs in terms of efficacy and tolerability in older adults with moderate-to-severe depression. Additional trials, possibly based on fixed doses of vortioxetine, are needed.
Registration: Clinicaltrials.gov: NCT03779789, registered on 12 Dec 2018; EudraCT number: 2018-001444-66.
期刊介绍：
Drugs & Aging delivers essential information on the most important aspects of drug therapy to professionals involved in the care of the elderly.
The journal addresses in a timely way the major issues relating to drug therapy in older adults including: the management of specific diseases, particularly those associated with aging, age-related physiological changes impacting drug therapy, drug utilization and prescribing in the elderly, polypharmacy and drug interactions.
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