論文

査読有り 国際誌
2020年8月

Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial.

Molecular psychiatry
  • Hidenori Yamasue
  • ,
  • Takashi Okada
  • ,
  • Toshio Munesue
  • ,
  • Miho Kuroda
  • ,
  • Toru Fujioka
  • ,
  • Yota Uno
  • ,
  • Kaori Matsumoto
  • ,
  • Hitoshi Kuwabara
  • ,
  • Daisuke Mori
  • ,
  • Yuko Okamoto
  • ,
  • Yuko Yoshimura
  • ,
  • Yuki Kawakubo
  • ,
  • Yuko Arioka
  • ,
  • Masaki Kojima
  • ,
  • Teruko Yuhi
  • ,
  • Keiho Owada
  • ,
  • Walid Yassin
  • ,
  • Itaru Kushima
  • ,
  • Seico Benner
  • ,
  • Nanayo Ogawa
  • ,
  • Yosuke Eriguchi
  • ,
  • Naoko Kawano
  • ,
  • Yukari Uemura
  • ,
  • Maeri Yamamoto
  • ,
  • Yukiko Kano
  • ,
  • Kiyoto Kasai
  • ,
  • Haruhiro Higashida
  • ,
  • Norio Ozaki
  • ,
  • Hirotaka Kosaka

25
8
開始ページ
1849
終了ページ
1858
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1038/s41380-018-0097-2

Although small-scale studies have described the effects of oxytocin on social deficits in autism spectrum disorder (ASD), no large-scale study has been conducted. In this randomized, parallel-group, multicenter, placebo-controlled, double-blind trial in Japan, 106 ASD individuals (18-48 y.o.) were enrolled between Jan 2015 and March 2016. Participants were randomly assigned to a 6-week intranasal oxytocin (48IU/day, n = 53) or placebo (n = 53) group. One-hundred-three participants were analyzed. Since oxytocin reduced the primary endpoint, Autism Diagnostic Observation Schedule (ADOS) reciprocity, (from 8.5 to 7.7; P < .001) but placebo also reduced the score (8.3 to 7.2; P < .001), no between-group difference was found (effect size -0.08; 95% CI, -0.46 to 0.31; P = .69); however, plasma oxytocin was only elevated from baseline to endpoint in the oxytocin-group compared with the placebo-group (effect size -1.12; -1.53 to -0.70; P < .0001). Among the secondary endpoints, oxytocin reduced ADOS repetitive behavior (2.0 to 1.5; P < .0001) compared with placebo (2.0 to 1.8; P = .43) (effect size 0.44; 0.05 to 0.83; P = .026). In addition, the duration of gaze fixation on socially relevant regions, another secondary endpoint, was increased by oxytocin (41.2 to 52.3; P = .03) compared with placebo (45.7 to 40.4; P = .25) (effect size 0.55; 0.10 to 1.0; P = .018). No significant effects were observed for the other secondary endpoints. No significant difference in the prevalence of adverse events was observed between groups, although one participant experienced temporary gynecomastia during oxytocin administration. Based on the present findings, we cannot recommend continuous intranasal oxytocin treatment alone at the current dose and duration for treatment of the core social symptoms of high-functioning ASD in adult men, although this large-scale trial suggests oxytocin's possibility to treat ASD repetitive behavior.

リンク情報
DOI
https://doi.org/10.1038/s41380-018-0097-2
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/29955161
ID情報
  • DOI : 10.1038/s41380-018-0097-2
  • ISSN : 1359-4184
  • PubMed ID : 29955161

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