Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial.
Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial.
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DOI：
10.1186/2040-2392-3-16
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发表时间：
2012-12-05
期刊：
影响因子：
6.2
通讯作者：
Hollander E
中科院分区：
文献类型：
--
作者：
Anagnostou E;Soorya L;Chaplin W;Bartz J;Halpern D;Wasserman S;Wang AT;Pepa L;Tanel N;Kushki A;Hollander E
目前还没有有效的药物治疗自闭症谱系障碍（ASD）的社会认知/功能缺陷，这方面的成人干预文献很少。来自动物模型和遗传关联研究以及早期单剂量干预研究的新兴数据表明，催产素系统可能是ASD中社会认知/功能缺陷的潜在治疗靶点。本研究的主要目的是检查鼻内催产素与安慰剂相比在ASD成人中的安全性/治疗效果，涉及两个核心症状领域：社会认知/功能和重复行为。这是一项在19名成人ASD患者（16名男性; 33.20 ± 13.29岁）中比较鼻内催产素与安慰剂的初步、随机、双盲、安慰剂对照、平行设计试验。受试者在上午和下午随机接受24 IU鼻内催产素或安慰剂，持续6周。测量社会功能/认知（非语言准确性诊断分析）和重复行为（重复行为量表修订版）。次要指标包括社会反应量表、眼内阅读测试和耶鲁布朗强迫症量表-强迫分量表和生活质量（世界卫生组织生活质量问卷-情感/社会分量表）。获得了全信息最大似然参数估计值，并使用混合效应回归分析进行了检验。虽然在校正基线差异后，在主要结果测量中没有发现显著变化，但结果表明6周后社会认知测量有所改善（眼内读心测试，p = 0.002，d = 1.2）和生活质量（世界卫生组织生活质量问卷-情绪，p = 0.031，d = 0.84），均为次要指标。催产素耐受性良好，未报告严重不良反应。这项初步研究表明，每天鼻内催产素给药对ASD成人有治疗潜力，需要进行更大规模和更长时间的研究。NCT00490802
There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors. This was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale – compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire – emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses. Although no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire – emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported. This pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted. NCT00490802
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