Department of Psychiatry, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Department of Neuroscience, Section of Psychiatry, Università Cattolica del Sacro Cuore, Rome, Italy.
J Psychopharmacol. 2024 Jul;38(7):615-623. doi: 10.1177/02698811241260996.
Data demonstrating the real-world, long-term effectiveness of vortioxetine in elderly patients with major depressive disorder (MDD) are clinically useful to confirm findings from randomized trials.
RELIEVE was a multinational, 24-week, observational, prospective study in outpatients with MDD initiating vortioxetine treatment in routine care settings (NCT03555136). Here, we report data from a subgroup of 130 patients aged ⩾ 65 years. The primary study outcome was changed from baseline in patient functioning assessed using the Sheehan Disability Scale (SDS). Other clinical outcomes included depression severity (Patient Health Questionnaire-9 [PHQ-9] and Clinical Global Impressions-Severity [CGI-S]), cognitive performance (Digit Symbol Substitution Test [DSST]) and symptoms (Perceived Deficits Questionnaire - Depression-5 item [PDQ-D-5]), and health-related quality of life (HRQoL) (EuroQoL 5 Dimensions 5 Levels [EQ-5D-5L]).
Clinically meaningful and statistically significant improvements in patient functioning, depressive symptoms, cognitive function, and HRQoL were observed at week 24. Least squares mean SDS, PHQ-9, CGI-S, PDQ-D-5, DSST, and EQ-5D-5L scores improved from baseline by 6.5, 5.7, 1.2, 3.2, 4.4, and 0.11 points, respectively ( < 0.01 for all). Adverse events were observed in 23.1% of patients.
Consistent with previous clinical studies of vortioxetine, this study supports the effectiveness and safety of vortioxetine in treating elderly patients with MDD in a real-world setting over a 6-month period. Patients showed clinically relevant and sustained improvements in psychosocial functioning, depressive symptoms, and cognitive function after receiving vortioxetine, which was generally well tolerated. Main study limitations include the open-label study design and lack of a placebo or comparator group.
在现实世界中展示维拉唑酮治疗老年抑郁症（MDD）患者的长期有效性的数据对于确认随机试验的发现具有临床意义。
RELIEVE 是一项多中心、24 周、观察性、前瞻性研究，在常规护理环境中接受维拉唑酮治疗的 MDD 门诊患者中进行（NCT03555136）。在这里，我们报告了年龄 ⩾ 65 岁的 130 例患者亚组的数据。主要研究结果是使用 Sheehan 残疾量表（SDS）评估的患者功能从基线的变化。其他临床结果包括抑郁严重程度（患者健康问卷-9 [PHQ-9]和临床总体印象严重程度 [CGI-S]）、认知表现（数字符号替代测试 [DSST]）和症状（感知缺陷问卷-抑郁 5 项 [PDQ-D-5]），以及健康相关生活质量（HRQoL）（EuroQoL 5 维度 5 水平 [EQ-5D-5L]）。
在第 24 周时观察到患者功能、抑郁症状、认知功能和 HRQoL 有临床意义和统计学意义的改善。SDS、PHQ-9、CGI-S、PDQ-D-5、DSST 和 EQ-5D-5L 的最小二乘均值分别从基线改善了 6.5、5.7、1.2、3.2、4.4 和 0.11 分（均<0.01）。观察到 23.1%的患者出现不良事件。
与维拉唑酮之前的临床研究一致，本研究支持维拉唑酮在现实环境中治疗老年 MDD 患者在 6 个月内的有效性和安全性。患者在接受维拉唑酮治疗后在社会心理功能、抑郁症状和认知功能方面表现出具有临床意义的持续改善，且一般耐受性良好。主要研究的局限性包括开放性研究设计和缺乏安慰剂或对照组。
