Oxytocin for Male Subjects with Autism Spectrum Disorder and Comorbid Intellectual Disabilities: A Randomized Pilot Study
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UNLABELLED: Approximately half of autism spectrum disorder (ASD) individuals suffer from comorbid intellectual disabilities (IDs). Oxytocin (OXT) receptors are highly expressed in temporal lobe structures and are likely to play a modulatory role in excitatory/inhibitory balance, at least based on animal model findings. Thus, it is feasible that in the highly representative group of Kanner-type ASD subjects, OXT could have a beneficial effect on social communication and social interaction. The aim of this pilot study is to investigate the feasibility and adverse events, such as epilepsy, of the long-term administration of intranasal OXT for adolescent and adult ASD subjects with ID because such patients frequently have seizures. We also addressed the question on how to scale the OXT effects to the core symptoms of social deficits because of the relative difficulty in obtaining objective measurements. Twenty-nine males (aged 15-40 years old) participated in a randomized, double-blind, and placebo-controlled crossover study (each for 8 weeks) with OXT (16 IU/day). Except for seizures experienced by one participant, other serious adverse events did not occur. The primary and secondary outcomes measured using the Childhood Autism Rating Scale and several standard scales, respectively, revealed no difference between the OXT and placebo groups. Instead, in an exploratory analysis, the social interactions observed in the play sessions or in daily life were significantly more frequent in the initial half period in the OXT-first arm of the crossover trial. There were also significant correlations between the plasma OXT concentration and subscale scores for irritability on the Aberrant Behavior Checklist. In conclusion, this pilot study demonstrates that long-term administration of intranasal OXT is tolerable in a representative cohort of ASD individuals with ID and suggests that future multicenter trials of OXT are warranted and should include measurements of reciprocal social interactions based on daily life under closer surveillance for epilepsy. TRIAL REGISTRATION: UMIN000007250.
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Long-term oxytocin administration can alleviate symptoms of autism spectrum disorder.
“Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD)”
Long-term oxytocin administration improves social-communicative skills in individuals with ASD.
“Previous findings also suggested that social-communicative skills, that is, Autism Diagnostic Observation Schedule reciprocity score5 and social interactions during the play sessions and daily life,6 were improved by long-term oxytocin administration;5, 6”
The failure to detect changes in social-communicative behaviors by IRSA may be because the assessment procedure used a videotaped interaction.
“Therefore, we could not detect changes in social-communicative behaviors by IRSA possibly because the assessment procedure used a videotaped interaction, in contrast to our findings of CGI-I score and those of previous trials.5, 6”
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- Authors
- Munesue, T., Nakamura, H., Kikuchi, M., Miura, Y., Takeuchi, N., Anme, T., Nanba, E., Adachi, K., Tsubouchi, K., Sai, Y., Miyamoto, K.-I., Horike, S.-I., Yokoyama, S., Nakatani, H., Niida, Y., Kosaka, H., Minabe, Y., & Higashida, H.
- Affiliations
- Kanazawa University (JP)
- University of Tsukuba (JP)
- Tottori University (JP)
- Kanazawa University Hospital (JP)
- University of Fukui (JP)
- Corresponding author
- Munesue, Toshio
- Higashida, Haruhiro
- ORCID
- Venue
- Frontiers in Psychiatry
- Publisher
- Frontiers Media SA
- Published
- 2016-01-21
- Volume
- 7
- Pages
- 2-2
- ISSN
- 1664-0640 (ISSN-L)
- PMC
- PMC4720778
- OpenAlex
- W2259158508
- Cited by
- 84
- References
- 68
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 7 · 2023: 5 · 2022: 14 · 2021: 10 · 2020: 6 · 2019: 10 · 2018: 10 · 2017: 14 · 2016: 2 · 2012: 1
- FWCI
- 18.87
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Frontiers in Psychiatry (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Institutional Repositories DataBase (IRDB) (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Terrestrial Environment Research Center (University of Tsukuba) (submittedVersion)
- Funders
- Kanazawa University
- Ministry of Education, Culture, Sports, Science and Technology
- Japan Society for the Promotion of Science (25381145, 15H01846, 25430167, 25293248, 26780271)
- 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
- oxytocin, autism spectrum disorder, intellectual disability, comorbidities, intranasal administration, social interaction, social communication, irritability, adverse events, epilepsy, adolescents and adults, feasibility
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