Inoue Takeshi, Fujimoto Shinji, Marumoto Tatsuro, Kitagawa Tadayuki, Ishida Kazuyuki, Nakajima Tadashi, Moriguchi Yoshiya, Fujikawa Keita, Watanabe Koichiro
Department of Psychiatry, Tokyo Medical University, Tokyo, Japan.
Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.
Neuropsychiatr Dis Treat. 2021 Dec 21;17:3781-3790. doi: 10.2147/NDT.S335028. eCollection 2021.
Antidepressants, including selective serotonin reuptake inhibitors, often elicit a poor response in patients with major depressive disorder (MDD) with significant anxiety symptoms. This study investigated the effects of the multimodal antidepressant vortioxetine in patients with MDD and associated anxiety.
This was a post hoc analysis of data from an 8-week, randomized, double-blind, placebo-controlled, Phase 3 study of vortioxetine (10 mg or 20 mg) in Japanese patients aged 20-75 years with recurrent MDD and a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 26. Changes from baseline to week 8 in MADRS total score and Hamilton Depression Rating Scale (HAM-D) anxiety/somatization factor score were assessed in patients with anxious depression (HAM-D anxiety/somatization factor score ≥7) and without anxious depression.
Data were available for 489 patients. In patients with anxious depression, the least-squares (LS) mean difference (95% confidence interval [CI]) versus placebo in change in MADRS total score was -3.44 (-6.10, -0.77) for vortioxetine 10 mg and -4.51 (-7.15, -1.87) for vortioxetine 20 mg. In patients with non-anxious depression, the LS mean difference (95% CI) versus placebo was -1.81 (-4.71, 1.09) and -1.05 (-4.00, 1.90) for vortioxetine 10 mg and 20 mg, respectively. Changes from baseline in HAM-D anxiety/somatization factor score were greater in patients treated with vortioxetine 10 mg or 20 mg than in those treated with placebo.
Vortioxetine may be effective for patients with anxiety symptoms in MDD. Further research is warranted to investigate these effects in a real-world clinical setting.
ClinicalTrials.gov identifier for primary study: NCT02389816.
包括选择性5-羟色胺再摄取抑制剂在内的抗抑郁药，在伴有显著焦虑症状的重度抑郁症（MDD）患者中，常常疗效不佳。本研究调查了多模式抗抑郁药伏硫西汀对MDD伴发焦虑患者的影响。
这是一项事后分析，数据来自一项为期8周、随机、双盲、安慰剂对照的3期研究，该研究针对年龄在20-75岁、患有复发性MDD且蒙哥马利-阿斯伯格抑郁评定量表（MADRS）得分至少为26的日本患者，给予伏硫西汀（10毫克或20毫克）治疗。对伴有焦虑性抑郁（汉密尔顿抑郁评定量表（HAM-D）焦虑/躯体化因子得分≥7）和不伴有焦虑性抑郁的患者，评估从基线到第8周MADRS总分和HAM-D焦虑/躯体化因子得分的变化。
489例患者有可用数据。在伴有焦虑性抑郁的患者中，与安慰剂相比，伏硫西汀10毫克组MADRS总分变化的最小二乘（LS）均值差（95%置信区间[CI]）为-3.44（-6.10，-0.77），伏硫西汀20毫克组为-4.51（-7.15，-1.87）。在不伴有焦虑性抑郁的患者中，与安慰剂相比，伏硫西汀10毫克组和20毫克组的LS均值差（95%CI）分别为-1.81（-4.71，1.09）和-1.05（-4.00，1.90）。与接受安慰剂治疗的患者相比，接受伏硫西汀10毫克或20毫克治疗的患者，其HAM-D焦虑/躯体化因子得分从基线的变化更大。
伏硫西汀可能对MDD伴有焦虑症状的患者有效。有必要进行进一步研究，以在真实临床环境中调查这些效果。
主要研究的ClinicalTrials.gov标识符：NCT02389816。
