Kasper Siegfried, Volz Hans-Peter, Möller Hans-Jürgen, Schläfke Sandra, Klement Stephan, Anghelescu Ion-George, Seifritz Erich
Center for Brain Research, Medical University of Vienna, Spitalgasse 4, 1090, Vienna, Austria.
Würzburg, Former Medical Director Hospital for Psychiatry, Psychotherapy and Psychosomatic Medicine Schloss Werneck, Werneck, Germany.
Eur Arch Psychiatry Clin Neurosci. 2024 Apr 1. doi: 10.1007/s00406-024-01783-2.
Anxiety and depressive disorders have overlapping symptoms and share common neurobiological pathways. Antidepressant drugs have been demonstrated to be efficacious in anxiety as well. Vice versa, it may also be promising to investigate the efficacy of anxiolytic drugs such as silexan in major depressive disorder (MDD). Patients with a mild or moderate, single or recurrent episode of MDD and a total score of 19-34 points on the Montgomery Åsberg Depression Rating Scale (MADRS) were randomized to receive 1 × 80 mg/d silexan, 1 × 50 mg/d sertraline, or placebo double-blind, double-dummy for 56 days. The primary outcome measure was the MADRS total score change between baseline and treatment end. Treatment groups were compared using a treatment policy estimand. 498 subjects (silexan 170, sertraline 171, placebo 157) were treated and analyzed. After 8 weeks, silexan and sertraline were superior to placebo for MADRS total score reduction, with absolute differences to placebo of 2.17 (95% confidence interval: 0.58; 3.76) points and 2.59 (1.02; 4.17) points, respectively (p < 0.01). Moreover, silexan was superior to placebo for alleviation of functional impairment according to the Sheehan Disability Scale with a difference of 2.40 (1.04; 3.76) points (p < 0.001). Both treatments were well tolerated; eructation was the most frequent adverse effect of silexan. The study confirms the antidepressant efficacy of silexan in mild or moderate MDD, including significant improvements in the subjects' functional capacity. The results for sertraline confirm the assay sensitivity of the trial. Both drugs were well tolerated.Trial registrationEudraCT2020-000688-22 first entered on 12/08/2020.
焦虑症和抑郁症有重叠的症状，并共享共同的神经生物学途径。抗抑郁药物已被证明对焦虑症也有效。反之亦然，研究诸如西酞普兰等抗焦虑药物对重度抑郁症（MDD）的疗效也可能很有前景。将蒙哥马利-艾斯伯格抑郁评定量表（MADRS）总分在19 - 34分的轻度或中度、单次或复发性MDD患者随机分为三组，分别接受每日1次80毫克的西酞普兰、每日1次50毫克的舍曲林或安慰剂，采用双盲、双模拟治疗56天。主要结局指标是基线至治疗结束时MADRS总分的变化。使用治疗策略估计值对治疗组进行比较。共治疗并分析了498名受试者（西酞普兰组170人，舍曲林组171人，安慰剂组157人）。8周后，西酞普兰和舍曲林在降低MADRS总分方面均优于安慰剂，与安慰剂的绝对差异分别为2.17（95%置信区间：0.58；3.76）分和2.59（1.02；4.17）分（p < 0.01）。此外，根据希恩残疾量表，西酞普兰在减轻功能损害方面优于安慰剂，差异为2.40（1.04；3.76）分（p < 0.001）。两种治疗耐受性均良好；嗳气是西酞普兰最常见的不良反应。该研究证实了西酞普兰在轻度或中度MDD中的抗抑郁疗效，包括受试者功能能力的显著改善。舍曲林的结果证实了该试验的检测敏感性。两种药物耐受性均良好。试验注册：EudraCT2020 - 000688 - 22，首次录入时间为2020年8月12日。
