Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

H. Kosaka*, Y. Okamoto, T. Munesue, H. Yamasue, K. Inohara, T. Fujioka, T. Anme, M. Orisaka, M. Ishitobi, M. Jung, T. X. Fujisawa, S. Tanaka, S. Arai, M. Asano, D. N. Saito, N. Sadato, A. Tomoda, M. Omori, M. Sato, H. OkazawaH. Higashida, Y. Wada

*この研究の対応する著者

研究成果: Article査読

80 被引用数 (Scopus)

抄録

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽ 21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽ 21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

本文言語English
論文番号e872
ジャーナルTranslational Psychiatry
6
8
DOI
出版ステータスPublished - 2016
外部発表はい

ASJC Scopus subject areas

  • 精神医学および精神衛生
  • 細胞および分子神経科学
  • 生物学的精神医学

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