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在自闭症临床试验中的安慰剂效应:从孕诺隆治疗研究中的经验

Joseph C McGrath¹, Jared Gong², John P Hegarty²

¹Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. joemcgrath@utexas.edu.

Journal of autism and developmental disorders

|July 18, 2025

概括

在自闭症谱系障碍 (ASD) 参与者中,为期两周的安慰剂引入显著降低了易怒性,证明了实质性的安慰剂效应. 这强调了在ASD治疗研究中需要安慰剂对照.

科学领域:

神经科学是一个神经科学.
精神病学是一个精神病学.
临床试验临床试验

背景情况:

假药效应在主观结果测量方面构成了重大挑战,特别是在自闭症谱系障碍 (ASD) 研究中.
对ASD治疗结果的高期望使安慰剂效应复杂化,需要在研究设计中仔细考虑.

研究的目的:

检查青少年和年轻成年人患有自闭症的安慰剂效应.
在ASD临床试验中,评估一个为期两周的安慰剂引入期在缓解安慰剂反应方面的疗效.

主要方法:

一个初步的试点研究包括一个单盲,为期两周的安慰剂领先在ASD随机对照试验之前.
异常行为检查清单 (ABC) 易怒度子表 (ABC-I) 是主要的结局指标.
分析了安慰剂效应的相关值,包括智商,年龄,性别和基线症状严重程度.

主要成果:

随着两周的安慰剂领先治疗 (p < 0.001) 后,观察到易怒症状减少了30.2%.
在其他ABC亚尺度中也注意到了显著的减少.
刺激性减少的程度与基线症状严重程度相关 (r=0.488,p=0.013),但与性别,智商或年龄无关.

结论:

这项试点试验提供了在ASD临床试验中显著安慰剂效应的证据.
一次盲目的安慰剂带入是一种推的策略,用于解释和减轻ASD干预研究中的安慰剂效应.

关键词:

自闭症谱系障碍 (ASD) 是一种临床试验临床试验烦躁易怒,容易生气.避孕药效应避孕药效应避孕药效应避孕药的引入者是安慰剂.孕产妇使用的孕.

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