Oxytocin and Autism Spectrum Disorders: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Abstract
Aim: Oxytocin presents an exciting potential to target the core symptoms of autism spectrum disorder (ASD) pharmacologically in an easily administered, cost-effective form with possibly minimal adverse effects. But, there are still major gaps in this area of research. This paper reviewed randomized controlled trials (RCTs) examining the effects of oxytocin administration on social cognition and restricted, repetitive behaviors in individuals with an ASD. Method: Electronic literature searches were conducted from PsycINFO, PubMed, Web of Knowledge, and EMBASE for RCTs published through June 2015. Results: 12 RCTs were included in this review. 7 out of the 11 studies that examined social cognition reported improvements. Additionally, one out of the 4 studies on restricted, repetitive behaviors, reported improvements following oxytocin administration. However, results from our meta-analyses suggest that oxytocin has no significant effect on these 2 domains. Conclusion: Previous evidence revealed mixed findings about the effects of oxytocin on ASD. Given the limited number of RCTs, our summary of findings on the effectiveness of oxytocin on ASD should still be considered tentative.
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The inconsistent results among these investigations may have been due to limited power or differences in participant age, oxytocin formulation or dose, treatment duration, outcome measures, or analytic methods.
“The inconsistent results among these various investigations may have been the result of limited power or differences in participant age, oxytocin formulation or dose, treatment duration, outcome measures, or analytic methods.22–24”
From Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder (2021) · cites this paper as [23]
Several clinical studies have investigated intranasal oxytocin as a treatment for ASD, but cannot provide a certain conclusion about its therapeutic potential.
“Several clinical studies have also investigated the potential of intranasal oxytocin as a treatment for socio-cognitive, behavioral, and socio-affective symptoms of ASD. So far, these studies cannot provide a certain conclusion about oxytocin’s therapeutic potential43–47.”
From Randomized clinical trial shows no substantial modulation of empathy-related neural activation by intranasal oxytocin in autism (2021) · cites this paper as [44]
The sample is larger than the average sample size of previous studies examining oxytocin effects on brain function in ASD and comparable to the average sample size in clinical trials examining oxytocin effects across different neurodevelopmental disorders.
“However, it must be noted that our sample is larger than the average sample size of previous studies examining oxytocin effects on brain function in ASD44, and comparable to the average sample size in clinical trials examining oxytocin effects across different neurodevelopmental disorders83.”
From Randomized clinical trial shows no substantial modulation of empathy-related neural activation by intranasal oxytocin in autism (2021) · cites this paper as [44]
Our findings are in line with recent meta-analytical evidence indicating that intranasal oxytocin only leads to small but non-significant changes in overall social cognition in ASD, but has no significant effect on emotion recognition and empathy.
“Importantly, our findings are in line with recent meta-analytical evidence indicating that intranasal oxytocin only leads to small but non-significant changes in overall social cognition in ASD44, but has no significant effect on emotion recognition and empathy83.”
From Randomized clinical trial shows no substantial modulation of empathy-related neural activation by intranasal oxytocin in autism (2021) · cites this paper as [44]
Intranasal oxytocin only leads to small but non-significant changes in overall social cognition in ASD.
“Importantly, our findings are in line with recent meta-analytical evidence indicating that intranasal oxytocin only leads to small but non-significant changes in overall social cognition in ASD44, but has no significant effect on emotion recognition and empathy83.”
From Randomized clinical trial shows no substantial modulation of empathy-related neural activation by intranasal oxytocin in autism (2021) · cites this paper as [44]
Only minimal adverse events have been reported in oxytocin ASD trials to date.
“Although only minimal adverse events have been reported in oxytocin ASD trials to date,69 it is still crucial to determine the lowest efficacious dose to limit adverse events and exposure to widely distributed peripheral oxytocin receptors.70”
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Dietary rescue of adult behavioral deficits in the Fmr1 knockout mouse
Nolan, S. O., Hodges, S. L., Binder, M. S., Smith, G. D., Okoh, J. T., Jefferson, T. S., Escobar, B., & Lugo, J. N. (2022) · PLoS ONE · doi:10.1371/journal.pone.0262916 · Cited by 9 · see citing works
Approaches to Improve the Quantitation of Oxytocin in Human Serum by Mass Spectrometry
Hering, A., Jieu, B., Jones, A., & Muttenthaler, M. (2022) · Frontiers in Chemistry · doi:10.3389/fchem.2022.889154 · Cited by 9 · see citing works
“In the process of developing such a method, we focused on OT as it is one of the most studied neuropeptide/ peptide hormone (including hundreds of clinical trials) due to its high relevance in social behavior and reproductive functions and its involvement in disorders such as autisms spectrum disorders, schizophrenia,…”
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Placebo Effects in the Neuroendocrine System: Conditioning of the Oxytocin Responses
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Breastfeeding patterns in infants are associated with a later diagnosis of autism Spectrum disorder
Elbedour, L., Balaum, R., Alhozyel, E., Meiri, G., Zigdon, D., Michaelovski, A., Kerub, O., & Menashe, I. (2024) · Autism Research · doi:10.1002/aur.3211 · Cited by 6 · see citing works
“Several meta-analyses have indicated that children with ASD have lower blood oxytocin levels than neurotypical children, suggesting that such early bonding between the mother and infant could affect ASD manifestation (John & Jaeggi, 2021; Ooi et al., 2017; Vanya et al., 2017).”
Relationship between oxytocin receptor gene polymorphism and hypertension in Turkish population
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“17,18 Possible explanations for the conflicting ( 3 4), and then once with the unknown mouse 2.”
Tereshchenko, S. Y., & Smolnikova, M. V. (2019) · S S Korsakov Journal of Neurology and Psychiatry · doi:10.17116/jnevro2019119121148 · Cited by 6 · see citing works
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“Oxytocin, an essential hormone in social behaviors [37], may assist in the treatment of the core symptoms of ASD [38].”
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Sex Differences in Neurodevelopment and Its Disorders
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Heralding a new era of oxytocinergic research: New tools, new problems?
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“However, studies of oxytocin levels in neurotypical and neuroatypical people show conflicting results [5].”
ResultChung, U., & Kim, J.-H. (2024) · Journal of korean Academy of Child and Adolescent Psychiatry · doi:10.5765/jkacap.230006 · Cited by 4 · see citing works
“However, oxytocin has no effects on social recognition and stereotype behavior in meta-analysis [33].”
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“…reviews examining exogenous oxytocin and social function across diverse clinical and control groups concluded that oxytocin had small or null effects on social functioning in clinical groups and small prosocial effects in control populations (Bakermans‐Kranenburg et al. 2013; Ooi et al. 2017).”
Overview of autism interventions
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Dissecting social decision-making: A spotlight on oxytocinergic transmission
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“As described, negative evidence exists for studies on neuropsychiatric (Dagani et al., 2016; Ooi et al., 2017; Williams and Bürkner, 2017; Sikich et al., 2021) and neurodegenerative (Leppanen et al.”
BackgroundResultInfluentialGirls With Autism—Any Sex-Based Peculiarities?
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Clinical convergence of autism, schizophrenia, and Alzheimer’s disease: The case of social cognition
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Yılmazer, E., Çınaroğlu, M., Köse, S. K., Ülker, S. V., & Tarlacı, S. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14196760 · Cited by 2 · see citing works
“Methodological variability is a key issue, with differences in biological sample types, assay sensitivity, collection timing, and participant characteristics such as age and clinical profile [12].”
- Authors
- Ooi, Y., Weng, S.-J., Kossowsky, J., Gerger, H., & Sung, M.
- Affiliations
- University of Basel (CH)
- National University of Singapore (SG)
- Boston Children's Hospital (US)
- Institute of Mental Health (SG)
- Corresponding author
- Ooi, Yoon
- Venue
- Pharmacopsychiatry
- Publisher
- Georg Thieme Verlag KG
- Published
- 2016-08-30
- Volume
- 50
- Issue
- 01
- Pages
- 5-13
- ISSN
- 0176-3679 (ISSN-L)
- 1439-0795
- OpenAlex
- W2514055214
- Cited by
- 131
- References
- 0
- Citations by year
- 2026: 2 · 2025: 8 · 2024: 9 · 2023: 17 · 2022: 14 · 2021: 30 · 2020: 14 · 2019: 11 · 2018: 11 · 2017: 12 · 2016: 2 · 2015: 1
- FWCI
- 1.88
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pharmacopsychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Science Foundation
- 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, social cognition, restricted and repetitive behaviors, pharmacotherapy, treatment effectiveness
- MeSH terms
- Autism Spectrum Disorder, Humans, Oxytocics, Oxytocin, Randomized Controlled Trials as Topic, Databases, Bibliographic
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