Effect of a Novel Nasal Oxytocin Spray With Enhanced Bioavailability on Autism: A Randomized Trial

IQ = intelligence quotient; SES = socioeconomic status, where a lower value indicates a higher socioeconomic status.

*P-values calculated from analyses performed by applying the mixed-effects model with the amount of change in each administration period as the response variable, with the content of administration (placebo, 3 U, 6 U, 1 0U, 20 U) and the order of administration (active drug→placebo/placebo→active drug) as the fixed effects, with the interaction between the content of administration and the order of administration, and with the effect of the individual as a random effect.
**P-values showing the minimum value.

Baseline, end point and change data are presented as mean (SD).
*The dose of contrast showing the smallest P-value for the dose–response relationship.
**P < 0.05 from paired t-tests.

Authors and Disclosures

Hidenori Yamasue^1,2, Masaki Kojima³, Hitoshi Kuwabara^1,2, Miho Kuroda⁴, Kaori Matsumoto⁵, Chieko Kanai⁶, Naoko Inada⁴, Keiho Owada⁷, Keiko Ochi⁸, Nobutaka Ono⁹, Seico Benner¹, Tomoyasu Wakuda¹, Yosuke Kameno¹, Jun Inoue¹⁰, Taeko Harada², Kenji Tsuchiya², Kazuo Umemura¹¹, Aya Yamauchi¹², Nanayo Ogawa¹³, Itaru Kushima¹³, Norio Ozaki¹³, Satoshi Suyama¹⁴, Takuya Saito¹⁴, Yukari Uemura¹⁵, Junko Hamada³, Yukiko Kano³, Nami Honda¹⁶, Saya Kikuchi¹⁶, Moe Seto¹⁶, Hiroaki Tomita¹⁶, Noriko Miyoshi¹⁷, Megumi Matsumoto¹⁷, Yuko Kawaguchi¹⁷, Koji Kanai¹⁷, Manabu Ikeda¹⁷, Itta Nakamura¹⁸, Shuichi Isomura¹⁸, Yoji Hirano¹⁸, Toshiaki Onitsuka¹⁸, Hirotaka Kosaka¹⁹ and Takashi Okada¹³

1 Department of Psychiatry, Hamamatsu University School of Medicine, 1–20-1 Handayama, Higashiku, Hamamatsu City 431–3192, Japan
2 Department of Child Development, United Graduate School of Child Development at Hamamatsu, 1–20-1 Handayama, Higashiku, Hamamatsu 431–3192, Japan
3 Department of Child Neuropsychiatry, School of Medicine, The University of Tokyo, 7–3-1 Hongo, Bunkyo-ku, Tokyo 113–8655, Japan
4 Department of Psychology, Faculty of Liberal Arts, Teikyo University, Tokyo, Japan
5 Graduate School of Psychology, Kanazawa Institute of Technology, 7–1 Ohgigaoka, Nonoichi 921–8054, Japan
6 Child Development and Education, Faculty of Humanities, Wayo Women's University, Konodai 2–3-1, Ichikawa, Chiba 272–0827, Japan
7 Department of Pediatrics, School of Medicine, The University of Tokyo, 7–3-1 Hongo, Bunkyo-ku, Tokyo 113–8655, Japan
8 School of Media Science, Tokyo University of Technology, Hachioji, Japan
9 Department of Computer Science, Graduate School of Systems Design, Tokyo Metropolitan University, Hino, Japan
10 Department of Child and Adolescent Psychiatry, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City 431–3192, Japan
11 Department of Pharmacology, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu City 431–3192, Japan
12 Department of Medical Technique, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466–8560, Japan
13 Department of Psychiatry, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466–8550, Japan
14 Department of Child and Adolescent Psychiatry, Hokkaido University Hospital, Sapporo, Japan
15 Biostatistics Section, Department of Data Science, Center for Clinical Science, National Center for Global Health and Medicine, Shinjyu-ku, Tokyo 162–8655, Japan
16 Department of Psychiatry, Graduate School of Medicine, Tohoku University, Sendai, Japan
17 Department of Psychiatry, Osaka University Graduate School of Medicine, Osaka, Japan
18 Department of Neuropsychiatry, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
19 Department of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui, Eiheiji, Fukui 910–1193, Japan

Correspondence to
H. Yamasue Department of Psychiatry, Hamamatsu University School of Medicine 1-20-1 Handayama, Higashiku, Hamamatsu City 431–3192, Japan E-mail: yamasue@hama-med.ac.jp