Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Mental Health Research Center, Iran University of Medical Sciences, Tehran, Iran.
J Clin Pharm Ther. 2020 Aug;45(4):804-811. doi: 10.1111/jcpt.13177. Epub 2020 May 18.
Major depressive disorder (MDD) is a complex disease and one of the leading contributors to disease burden throughout the world. In the current study, we explored the efficacy and tolerability of vortioxetine versus sertraline on symptoms of depression in elderly patients with MDD.
Sixty patients diagnosed with MDD (based on DSM-5) and Hamilton Depression Rating Scale (HAM-D) score ≥ 19 were entered into a randomized double-blind study and were randomized to receive either vortioxetine (15 mg daily) or sertraline (75 mg daily) for six weeks. Patients were assessed using the HAM-D scale at baseline and weeks 3 and 6. Changes in HAM-D score, response rates, remission rate and time to response or remission were also compared between the two study groups.
Fifty patients completed the trial after six weeks. General linear model repeated measures demonstrated no difference in trend of the two treatment groups (P = .897). There was no significantly different improvement in the HDRS scores from baseline to weeks 3 and 6, as well. Differences in response rate, remission rate, time to response and time to remission periods were not statistically significant. Finally, there was not any significantly difference between the two study groups in the frequency of adverse events.
This study showed no significant differences in the efficacy and safety of vortioxetine in comparison with sertraline in order for it to be used safely for treatment of major depressive disorder in elderly patients.
重度抑郁症(MDD)是一种复杂的疾病,也是导致全球疾病负担的主要原因之一。在目前的研究中,我们探讨了文拉法辛与舍曲林治疗老年 MDD 患者抑郁症状的疗效和耐受性。
60 名符合 DSM-5 标准且汉密尔顿抑郁量表(HAM-D)评分≥19 的 MDD 患者进入随机双盲研究,随机分为文拉法辛(15mg/d)或舍曲林(75mg/d)治疗组,疗程 6 周。分别在基线和第 3、6 周末采用 HAM-D 量表评估。比较两组间 HAM-D 评分变化、应答率、缓解率及达到应答或缓解的时间。
6 周后,50 名患者完成了试验。重复测量的一般线性模型显示两组的趋势无差异(P=0.897)。HAM-D 评分从基线到第 3、6 周末的改善也无显著差异。应答率、缓解率、达到应答和缓解的时间差异均无统计学意义。最后,两组间不良反应的频率也无显著差异。
该研究表明,文拉法辛在治疗老年 MDD 患者方面的疗效和安全性与舍曲林无显著差异,可安全使用。