Berardelli Isabella, Rogante Elena, Formica Federico, Iannazzo Riccardo, Mammoliti Attilio Valerio, Riccioni Raffaele, Veizi Skender, McIntyre Roger S, Pompili Maurizio
Faculty of Medicine and Psychology, Department of Neurosciences, Mental Health, and Sensory Organs, Suicide Prevention Center, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Lazio, Italy.
Department of Human Neursciences, Sapienza University of Rome, Rome, Italy.
J Psychopharmacol. 2025 Feb;39(2):92-105. doi: 10.1177/02698811241309612. Epub 2025 Feb 1.
Among the available pharmacological treatments for acute major depressive disorder (MDD), vortioxetine, a serotonin transporter inhibitor (SERT), has been widely used for its multimodal action on serotonin neurotransmission, which produces essential changes also on glutamate, gamma amino butyric acid (GABA), norepinephrine, acetylcholine, and dopamine.
This systematic review and meta-analysis aimed to evaluate the acute efficacy of vortioxetine across multiple dosing and to evaluate whether there is a dose-response effect and as well there is a dose-response issue with respect to side effects in acute depression.
According to PRISMA guidelines, we systematically searched three major electronic databases (PubMed/MEDLINE, PsycINFO, and Cochrane Central Register of Controlled Trials) for Randomized Controlled Trial (RCT) studies published between January 2013 and April 2024. Twenty-four studies were included in the review and two meta-analyses were conducted to determine whether the mean Montgomery-Asberg Depression Rating Scale (MADRS) scale values in the placebo groups differ significantly from the mean MADRS scale values in the group receiving vortioxetine 10 mg or vortioxetine 20 mg.
Vortioxetine significantly improved acute depression severity, anxiety symptoms, and cognitive function, with high response and remission rates in acute MDD. It was also well tolerated with a relatively low occurrence of severe or serious treatment-emergent adverse events (TEAEs). Observing the results of the meta-analysis, the effect was significant for both vortioxetine 10 and 20 mg, with a greater effect size for vortioxetine 20 mg.
Vortioxetine should be considered efficacious as a first- and second-line therapy.
在现有的急性重度抑郁症（MDD）药物治疗中，伏硫西汀作为一种5-羟色胺转运体抑制剂（SERT），因其对5-羟色胺神经传递的多模式作用而被广泛使用，这种作用也会对谷氨酸、γ-氨基丁酸（GABA）、去甲肾上腺素、乙酰胆碱和多巴胺产生重要影响。
本系统评价和荟萃分析旨在评估伏硫西汀在多个剂量下的急性疗效，并评估是否存在剂量反应效应，以及在急性抑郁症中副作用方面是否存在剂量反应问题。
根据PRISMA指南，我们系统检索了三个主要电子数据库（PubMed/MEDLINE、PsycINFO和Cochrane对照试验中央注册库），以查找2013年1月至2024年4月发表的随机对照试验（RCT）研究。本评价纳入了24项研究，并进行了两项荟萃分析，以确定安慰剂组的平均蒙哥马利-艾斯伯格抑郁量表（MADRS）评分值与接受10mg或20mg伏硫西汀组的平均MADRS评分值是否有显著差异。
伏硫西汀显著改善了急性抑郁症的严重程度、焦虑症状和认知功能，在急性MDD中具有较高的缓解率和治愈率。它的耐受性也很好，严重或严重的治疗中出现的不良事件（TEAE）发生率相对较低。观察荟萃分析的结果，伏硫西汀10mg和20mg的疗效均显著，20mg伏硫西汀的效应量更大。
伏硫西汀应被视为一线和二线治疗的有效药物。
