Watanabe Koichiro, Fujimoto Shinji, Marumoto Tatsuro, Kitagawa Tadayuki, Ishida Kazuyuki, Nakajima Tadashi, Moriguchi Yoshiya, Fujikawa Keita, Inoue Takeshi
Department of Neuropsychiatry, Kyorin University School of Medicine, Tokyo, Japan.
Japan Medical Office, Takeda Pharmaceutical Co., Ltd, Tokyo, Japan.
Neuropsychiatr Dis Treat. 2022 Feb 19;18:363-373. doi: 10.2147/NDT.S340281. eCollection 2022.
Anhedonia in major depressive disorder may be resistant to first-line antidepressants. We examined the effect of vortioxetine, a multimodal antidepressant, on anhedonia-like symptoms in Japanese patients with major depressive disorder.
This was a post hoc analysis of 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 major depressive disorder and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of at least 26. The primary outcome was the mean change from baseline to week 8 in anhedonia-like symptoms as measured by MADRS anhedonia factor score, composed of: Q1, apparent sadness; Q2, reported sadness; Q6, concentration; Q7, lassitude; and Q8, inability to feel. Mean change in MADRS total score and anhedonia factor score were compared among treatment groups, with data categorized by median baseline anhedonia factor score (0-17 or ≥18).
Data were available for 489 patients. The least-squares mean difference in MADRS anhedonia factor score change from baseline to week 8 versus placebo was -1.34 for vortioxetine 10 mg ( = 0.0300) and -1.77 for vortioxetine 20 mg ( = 0.0044). The least-squares mean difference between vortioxetine and placebo in MADRS total score change from baseline to week 8 was -3.11 (10 mg dose) and -3.37 (20 mg dose) for patients with a higher baseline anhedonia factor score (≥18), and -2.08 (10 mg) and -2.61 (20 mg) for patients with a lower baseline score (0-17).
This post hoc analysis suggests that vortioxetine may have therapeutic potential in patients with anhedonia-like symptoms of major depressive disorder. ClinicalTrials.gov identifier for primary study: NCT02389816.
重度抑郁症中的快感缺失可能对一线抗抑郁药有抗性。我们研究了多模式抗抑郁药伏硫西汀对日本重度抑郁症患者快感缺失样症状的影响。
这是一项对伏硫西汀(10毫克或20毫克)在年龄为20 - 75岁、患有复发性重度抑郁症且蒙哥马利-Åsberg抑郁评定量表(MADRS)总分至少为26的日本患者中进行的为期8周的随机、双盲、安慰剂对照3期研究的事后分析。主要结局是通过MADRS快感缺失因子评分(由以下组成:Q1,明显悲伤;Q2,自述悲伤;Q6,注意力;Q7,倦怠;Q8,无法感受)测量的从基线到第8周快感缺失样症状的平均变化。比较治疗组之间MADRS总分和快感缺失因子评分的平均变化,数据按基线快感缺失因子评分中位数(0 - 17或≥18)分类。
有489名患者的数据可用。与安慰剂相比,从基线到第8周,伏硫西汀10毫克组MADRS快感缺失因子评分变化的最小二乘均值差异为-1.34(P = 0.0300),伏硫西汀20毫克组为-1.77(P = 0.0044)。对于基线快感缺失因子评分较高(≥18)的患者,从基线到第8周,伏硫西汀与安慰剂在MADRS总分变化方面的最小二乘均值差异为-3.11(10毫克剂量)和-3.37(20毫克剂量);对于基线评分较低(0 - 17)的患者,差异为-2.08(10毫克)和-2.61(20毫克)。
这项事后分析表明,伏硫西汀可能对重度抑郁症快感缺失样症状患者具有治疗潜力。主要研究的ClinicalTrials.gov标识符:NCT02389816。