Effect of intranasal oxytocin on the core social symptoms of autism spectrum disorder: a randomized clinical trial
Abstract
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.
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Small randomized controlled trials of intranasal oxytocin administered for 4 to 24 weeks in persons with autism spectrum disorder have had equivocal results regarding improvements in social functioning, social cognition, or social attention.
“Small, randomized, controlled trials of intranasal oxytocin administered for 4 to 24 weeks in persons with autism spectrum disorder have had equivocal results with regard to oxytocin-associated improvements in social functioning, social cognition, or social attention.18–21”
From Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder (2021) · cites this paper as [20]
The Sikich et al. results provide strong evidence that children should not be prescribed chronic intranasal oxytocin independently of context.
“provide strong evidence that children should not be prescribed chronic intranasal oxytocin independently of context7”
From Refining oxytocin therapy for autism: context is key (2022) · cites this paper as [7]
There is now compelling evidence that chronic administration of oxytocin is not beneficial.
“now we have compelling evidence that chronic administration of oxytocin is not beneficial”
From Refining oxytocin therapy for autism: context is key (2022) · cites this paper as [7]
The Sikich et al. results align with those of a clinical trial from Japan published in 2020.
“these results align with those of a clinical trial from Japan, published in 2020”
From Refining oxytocin therapy for autism: context is key (2022) · cites this paper as [7]
There are failures of replication in well-powered IN-OT clinical trials for ASD that urge caution in supporting IN-OT alone as a therapy.
“There are, however, failures of replication in well-powered IN-OT clinical trials for ASD that urge caution in supporting IN-OT alone as a therapy [50].”
From Translational opportunities for circuit-based social neuroscience: advancing 21st century psychiatry (2021) · cites this paper as [50]
All OXT trials in adults with ASD studied only short-term benefits (within a few weeks).
“However, all these trials studied only short-term benefits (within a few weeks) of OXT administration.”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [77]
The effects of OXT in ASD are likely modulated by age, gender, and possibly genetic factors.
“It is also likely that the effects of OXT in ASD are modulated by age, gender, and possibly genetic factors [77, 79, 90].”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [77]
There have been generally positive results of OXT in adults with ASD, with trials showing improvements in repetitive behaviors, social reciprocity, and emotion recognition.
“There have been generally positive results of OXT in adults with ASD, with trials showing improvements in repetitive behaviors, social reciprocity, and emotion recognition [75–77].”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [77]
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- Authors
- Yamasue, H., Okada, T., Munesue, T., Kuroda, M., Fujioka, T., Uno, Y., Matsumoto, K., Kuwabara, H., Mori, D., Okamoto, Y., Yoshimura, Y., Kawakubo, Y., Arioka, Y., Kojima, M., Yuhi, T., Owada, K., Yassin, W., Kushima, I., Benner, S., Ogawa, N., Eriguchi, Y., Kawano, N., Uemura, Y., Yamamoto, M., Kano, Y., Kasai, K., Higashida, H., Ozaki, N., & Kosaka, H.
- Affiliations
- Hamamatsu University (JP)
- Nagoya University (JP)
- Kanazawa University (JP)
- The University of Tokyo (JP)
- University of Fukui (JP)
- McLean Hospital (US)
- Kanazawa Institute of Technology (JP)
- Brain & Mind Research Center, Nagoya University (JP)
- University of Tokyo Hospital (JP)
- Corresponding author
- Yamasue, Hidenori
- ORCID
- Yamasue, Hidenori
- Okada, Takashi
- Kuroda, Miho
- Uno, Yota
- Matsumoto, Kaori
- Kuwabara, Hitoshi
- Mori, Daisuke
- Okamoto, Yuko
- Yoshimura, Yuko
- Kawakubo, Yuki
- Arioka, Yuko
- Kojima, Masaki
- Yuhi, Teruko
- Owada, Keiho
- Yassin, Walid
- Kushima, Itaru
- Benner, Seico
- Ogawa, Nanayo
- Eriguchi, Yosuke
- Kawano, Naoko
- Uemura, Yukari
- Yamamoto, Maeri
- Kano, Yukiko
- Kasai, Kiyoto
- Higashida, Haruhiro
- Ozaki, Norio
- Kosaka, Hirotaka
- Venue
- Molecular Psychiatry
- Published
- 2018-06-29
- Volume
- 25
- Issue
- 8
- Pages
- 1849-1858
- ISSN
- 1359-4184 (ISSN-L)
- 1476-5578
- OpenAlex
- W2809900380
- Semantic Scholar
- 50d2e6cb5185367d8ed161add20c882139d0d756
- Cited by
- 185
- References
- 45
- Citations by year
- 2026: 15 · 2025: 16 · 2024: 24 · 2023: 21 · 2022: 31 · 2021: 34 · 2020: 22 · 2019: 16 · 2018: 6
- FWCI
- 26.39
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Molecular Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Japan Agency for Medical Research and Development (the Strategic Research Program for Brain Sciences)
- Topics
- Social Sciences › Psychology › Social Psychology › Neuroendocrine regulation and behavior
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetics and Neurodevelopmental Disorders
- Keywords
- autism spectrum disorder, intranasal oxytocin, social dysfunction, reciprocity, repetitive behavior, visual fixation, plasma oxytocin, placebo effect, high-functioning adults, social cognition, gynecomastia, adverse events, treatment efficacy
- MeSH terms
- Autism Spectrum Disorder, Administration, Intranasal, Adolescent, Adult, Double-Blind Method, Gynecomastia, Humans, Japan, Male, Middle Aged, Oxytocin, Young Adult
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