Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
Rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B).
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DOI：
10.1016/j.cct.2020.106103
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发表时间：
2020-11
影响因子：
2.2
通讯作者：
Sikich L
中科院分区：
文献类型：
--
作者：
Spanos M;Chandrasekhar T;Kim SJ;Hamer RM;King BH;McDougle CJ;Sanders KB;Gregory SG;Kolevzon A;Veenstra-VanderWeele J;Sikich L
描述自闭症卓越中心（ACE）自闭症催产素改善互惠社会行为（SOARS-B）网络研究的原理、设计和方法。这项2期临床试验旨在评估使用鼻内催产素治疗来改善自闭症谱系障碍（ASD）患者的社交困难。总共有290名年龄在3到17岁之间，DSM-5诊断为ASD的参与者被招募接受24周的催产素或匹配的安慰剂治疗。参与者随后接受开放标签催产素治疗24周。在治疗停止后4周进行治疗后评估。在基线、第8、24和36周测量血浆催产素和催产素受体基因（OXTR）甲基化水平，以探索这些生物标志物与治疗反应之间的潜在关系。本报告描述了SOARS-B临床试验的原理、设计和方法。对于靶向ASD的核心症状的有效药物治疗选择存在巨大的未满足的需求。一些研究支持这一假设，即鼻内催产素可以改善ASD患者的社会定向和社会奖励的显着性，从而增强互惠的社会行为。然而，由于一些关于外源性催产素的亲社会效应的初步研究结果相互矛盾，这一假设仍然存在争议和不确定性。SOARS-B是迄今为止解决这一假设的最佳功效研究，并有望提高我们对鼻内催产素治疗ASD儿童社交缺陷的安全性和有效性的理解。
To describe the rationale, design, and methods of the Autism Centers of Excellence (ACE) network Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B). This phase 2 clinical trial was designed to evaluate the use of intranasal oxytocin treatment to improve social difficulties in individuals with autism spectrum disorder (ASD). In total, 290 participants ages 3 to 17 years with a DSM-5 diagnosis of ASD were enrolled to receive 24 weeks of treatment with either oxytocin or a matched placebo. Participants were subsequently treated with open-label oxytocin for 24 additional weeks. Post-treatment assessments were done 4 weeks after treatment discontinuation. Plasma oxytocin and oxytocin receptor gene (OXTR) methylation level were measured at baseline, week 8, 24 and 36 to explore potential relationships between these biomarkers and treatment response. This report describes the rationale, design, and methods of the SOARS-B clinical trial. There is a tremendous unmet need for effective pharmacological treatment options that target the core symptoms of ASD. Several studies support the hypothesis that intranasal oxytocin could improve social orienting and the salience of social rewards in ASD, thereby enhancing reciprocal social behaviors. However, due to conflicting results from a number of pilot studies on the prosocial effects of exogenous oxytocin, this hypothesis remains controversial and inconclusive. SOARS-B is the best powered study to date to address this hypothesis and promises to improve our understanding of the safety and efficacy of intranasal oxytocin in the treatment of social deficits in children with ASD.
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影响因子：
6.2
作者：
Anagnostou E;Soorya L;Chaplin W;Bartz J;Halpern D;Wasserman S;Wang AT;Pepa L;Tanel N;Kushki A;Hollander E
通讯作者：
Hollander E
影响因子：
4.9
作者：
Campbell, Daniel B.;Datta, Dibyadeep;Jones, Shaine T.;Lee, Evon Batey;Sutcliffe, James S.;Hammock, Elizabeth A. D.;Levitt, Pat
通讯作者：
Levitt, Pat
影响因子：
3.9
作者：
Cohen, IL;Schmidt-Lackner, S;Sudhalter, V
通讯作者：
Sudhalter, V
影响因子：
3.9
作者：
Constantino, JN;Davis, SA;Reich, W
通讯作者：
Reich, W
影响因子：
10.5
作者：
Feldman, Ruth;Golan, Ofer;Zagoory-Sharon, Orna
通讯作者：
Zagoory-Sharon, Orna