Objective: Generalized anxiety disorder (GAD) in children and adolescents is associated with substantial morbidity and increases the risk of future psychopathology. However, relatively few psychopharmacologic studies have examined treatments for GAD in pediatric populations, especially in prepubertal youth. Methods: Children and adolescents aged 7-17 years of age with a primary diagnosis of GAD were treated with flexibly dosed escitalopram (10-20 mg daily, n = 138) or placebo (n = 137) for 8 weeks. Efficacy measures included the Pediatric Anxiety Rating Scale (PARS) for GAD, Clinical Global Impression of Severity (CGI-S) scale, Children's Global Assessment Scale (CGAS); safety measures included the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as adverse events (AEs), vital signs, and electrocardiographic and laboratory monitoring. Results: Escitalopram was superior to placebo in reducing anxiety symptoms of GAD, as seen in the difference in mean change from baseline to week 8 on the PARS severity for GAD score (least squares mean difference = -1.42; p = 0.028). Functional improvement, as reflected by CGAS score, was numerically greater in escitalopram-treated patients compared with those receiving placebo (p = 0.286), and discontinuation owing to AEs did not differ between the two groups. Vital signs, weight, laboratory, and electrocardiographic results were consistent with previous pediatric studies of escitalopram. Conclusions: Escitalopram reduced anxiety symptoms and was well tolerated in pediatric patients with GAD. These findings confirm earlier reports of escitalopram efficacy in adolescents aged 12-17 years and extend the safety and tolerability data to children with GAD aged 7-11 years. ClinicalTrials.gov Identifier: NCT03924323.

中文翻译：

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艾司西酞普兰治疗患有广泛性焦虑症的儿童和青少年的多中心双盲、安慰剂对照试验。

目的：儿童和青少年的广泛性焦虑症（GAD）与大量发病率相关，并增加未来精神病理学的风险。然而，相对较少的精神药理学研究探讨了儿童群体（尤其是青春期前青少年）广泛性焦虑症（GAD）的治疗方法。方法：初步诊断为 GAD 的 7-17 岁儿童和青少年接受灵活剂量的艾司西酞普兰（每天 10-20 毫克，n = 138）或安慰剂（n = 137）治疗 8 周。功效测量包括儿童广泛性焦虑症焦虑评定量表（PARS）、严重程度临床总体印象（CGI-S）量表、儿童总体评估量表（CGAS）；安全措施包括哥伦比亚自杀严重程度评定量表（C-SSRS）以及不良事件（AE）、生命体征以及心电图和实验室监测。结果：艾司西酞普兰在减少 GAD 焦虑症状方面优于安慰剂，从基线到第 8 周的 GAD 评分 PARS 严重程度平均变化差异即可看出（最小二乘平均差 = -1.42；p = 0.028）。与接受安慰剂的患者相比，CGAS 评分所反映的功能改善在数值上更大（p = 0.286），并且两组之间因 AE 导致的停药没有差异。生命体征、体重、实验室和心电图结果与先前的艾司西酞普兰儿科研究一致。结论：艾司西酞普兰可减轻 GAD 儿童患者的焦虑症状，且耐受性良好。这些发现证实了先前关于艾司西酞普兰对 12-17 岁青少年疗效的报道，并将安全性和耐受性数据扩展到 7-11 岁的广泛性焦虑症儿童。ClinicalTrials.gov 标识符：NCT03924323。