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首页> 外文期刊>International clinical psychopharmacology >Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study
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Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study

机译：泛型焦虑症患者中的维拉唑酮：一项双盲，随机，安慰剂对照，灵活剂量研究

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Vilazodone is a selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist that is approved for treatment of major depressive disorder in adults in the USA and Mexico. The efficacy, safety, and tolerability of vilazodone for generalized anxiety disorder (GAD) were investigated in a clinical trial (NCT01766401 ClinicalTrials. gov). Participants (18-70 years, inclusive) who met Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text revision, criteria for GAD were randomized (1 : 1) to placebo or flexible-dose vilazodone (20-40 mg/day) for 8 weeks of double-blind treatment. Primary and secondary efficacy parameters were changes from baseline to week 8 in Hamilton Rating Scale for Anxiety and Sheehan Disability Scale total scores, respectively. Analysis was based on a mixed-effects model for repeated measures approach on the intent-to-treat population. The intent-to-treat population comprised 395 patients (placebo = 197, vilazodone = 198); 77% completed the study. The least squares mean difference in change from baseline to week 8 in the Hamilton Rating Scale for Anxiety total score was statistically significant for vilazodone versus placebo [-1.50 (-2.96, -0.04), P = 0.0438]. The mean change from baseline to week 8 in the Sheehan Disability Scale total score for vilazodone versus placebo was not statistically significant. Adverse events were reported in 60% of placebo-treated and 83% of vilazodone-treated patients. This was a positive clinical trial of 20-40 mg/day vilazodone versus placebo in the treatment of GAD. Copyright (C) 2015 Wolters Kluwer Health, Inc. All rights reserved.
机译：Vilazodone是选择性5-羟色胺再摄取抑制剂和5-HT1A受体部分激动剂，已被批准用于治疗美国和墨西哥成年人的主要抑郁症。在一项临床试验（NCT01766401 ClinicalTrials。gov）中研究了维拉唑酮对广泛性焦虑症（GAD）的疗效，安全性和耐受性。符合《精神障碍诊断和统计手册》第4版，文本修订和GAD标准的参与者（18-70岁，包括18岁至70岁）被随机分配（1：1）为安慰剂或弹性剂量维拉唑酮（20-40 mg /天） ）进行8周的双盲治疗。主要和次要疗效参数分别是从基线到第8周的汉密尔顿焦虑量表和Sheehan残疾量表总分的变化。分析是基于混合效应模型的意向性治疗人群的重复测量方法。意向性治疗人群包括395例患者（安慰剂= 197，维拉唑酮= 198）; 77％的人完成了研究。汉密尔顿焦虑量表总分中从基线到第8周变化的最小二乘均值差异在维拉唑酮与安慰剂组中有统计学意义[-1.50（-2.96，-0.04），P = 0.0438]。维拉唑酮与安慰剂相比，希恩残疾量表总得分从基线到第8周的平均变化无统计学意义。据报道，有60％的安慰剂治疗患者和83％的维拉唑酮治疗患者发生了不良事件。这是20-40毫克/天的维拉唑酮与安慰剂治疗GAD的阳性临床试验。版权所有（C）2015 Wolters Kluwer Health，Inc.保留所有权利。

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