Gommoll Carl, Forero Giovanna, Mathews Maju, Nunez Rene, Tang Xiongwen, Durgam Suresh, Sambunaris Angelo
aForest Research Institute, an affiliate of Actavis Inc., Harborside Financial Center, Jersey City, New Jersey bAtlanta Institute of Medicine & Research, Atlanta, Georgia, USA.
Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096.
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.
维拉佐酮是一种选择性5-羟色胺再摄取抑制剂及5-羟色胺1A受体部分激动剂，在美国和墨西哥被批准用于治疗成人重度抑郁症。在一项临床试验（NCT01766401，ClinicalTrials.gov）中研究了维拉佐酮治疗广泛性焦虑症（GAD）的疗效、安全性及耐受性。符合《精神疾病诊断与统计手册》第4版，修订版中GAD标准的参与者（年龄18 - 70岁，含18岁和70岁）被随机（1:1）分配至安慰剂组或灵活剂量维拉佐酮组（20 - 40毫克/天），进行为期8周的双盲治疗。主要和次要疗效参数分别为从基线至第8周汉密尔顿焦虑量表总分及希恩残疾量表总分的变化。分析基于意向性治疗人群的重复测量混合效应模型。意向性治疗人群包括395例患者（安慰剂组 = 197例，维拉佐酮组 = 198例）；77%完成了研究。维拉佐酮组与安慰剂组相比，从基线至第8周汉密尔顿焦虑量表总分变化的最小二乘均值差异具有统计学意义[-1.50（-2.96，-0.04），P = 0.0438]。维拉佐酮组与安慰剂组相比，从基线至第8周希恩残疾量表总分的平均变化无统计学意义。60%接受安慰剂治疗的患者和83%接受维拉佐酮治疗的患者报告了不良事件。这是一项比较20 - 40毫克/天维拉佐酮与安慰剂治疗GAD的阳性临床试验。
