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首页> 外文期刊>Human psychopharmacology: clinical and experimental >A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder
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A randomized, double-blind, fixed-dose study comparing the efficacy and tolerability of vortioxetine 2.5 and 10 mg in acute treatment of adults with generalized anxiety disorder

机译：一项随机，双盲，固定剂量研究，比较了伏替西汀2.5和10 mg在成人广泛性焦虑症的急性治疗中的疗效和耐受性

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Background Vortioxetine is a recently approved multimodal antidepressant with anxiolytic properties in preclinical studies. Objective This double-blind, placebo-controlled study assessed the efficacy and tolerability of vortioxetine in subjects with a primary diagnosis of generalized anxiety disorder. Methods Subjects (n = 457) were randomized 1:1:1 to treatment with placebo or vortioxetine 2.5 or 10 mg once daily. The primary efficacy endpoint was reduction in Hamilton Anxiety Scale (HAM-A) total scores from baseline after 8 weeks of treatment. Key secondary outcomes were changes from baseline in HAM-A total scores for the 2.5 and 10 mg dose, Hospital Anxiety and Depression anxiety subscore, 36-Item Short-Form Health Survey, Sheehan Disability Scale, and Clinical Global Impression-Improvement Scale score, as well as HAM-A response rate at week 8. Results Neither vortioxetine dose achieved a statistically significant improvement over placebo on the primary endpoint (least-squares mean difference ± standard error from placebo: -0.87 ± 0.803 [p = 0.279] for 2.5 mg and -0.81 ± 0.791 [p = 0.306] for 10 mg vortioxetine) or on any secondary efficacy endpoints. Common adverse events (≥5% in either vortioxetine group) were nausea, dry mouth, headache, diarrhea, constipation, and vomiting. Conclusions Vortioxetine 2.5 and 10 mg treatment did not significantly improve generalized anxiety disorder symptoms versus placebo. Vortioxetine was safe and well tolerated in this patient population.
机译：背景伏替西汀是最近被批准的多峰抗抑郁药，在临床前研究中具有抗焦虑特性。目的这项双盲，安慰剂对照的研究评估了伏替西汀在初步诊断为广泛性焦虑症的受试者中的疗效和耐受性。方法受试者（n = 457）以1：1：1的比例随机接受安慰剂或伏立西汀2.5或10 mg每天一次的治疗。主要功效终点是治疗8周后汉密尔顿焦虑量表（HAM-A）总分较基线水平降低。关键的次要结局是2.5和10 mg剂量HAM-A总分与基线的变化，医院焦虑和抑郁焦虑分值，36项简短健康调查，Sheehan残疾量表和临床总体印象改善量表得分，以及第8周的HAM-A响应率。结果伏立西汀的主要终点指标均未达到安慰剂统计学上的显着改善（最小二乘均方差±安慰剂标准误：2.5的-0.87±0.803 [p = 0.279]伏替西汀10毫克）和-0.81±0.791 [p = 0.306]或任何次要疗效终点。常见不良事件（伏替西汀组≥5％）为恶心，口干，头痛，腹泻，便秘和呕吐。结论与安慰剂相比，伏替西汀2.5和10 mg治疗不能显着改善广泛性焦虑症的症状。在该患者人群中，伏替西汀是安全的并且耐受性良好。

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