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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 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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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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“For example, Ooi et al. (2017) meta-analyzed RCT’s examining the effect of intranasal and intravenous OT administration on social cognition in ASD.”
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Intranasal oxytocin in the treatment of autism spectrum disorders: A multilevel meta-analysis
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Oxytocin levels tend to be lower in autistic children: A meta-analysis of 31 studies
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“Such a normalization of OT levels could explain why intranasal administration of OT in autistic adults often yields small or no effects on social function or repetitive behaviors (Peled-Avron et al., 2020; Phaik Ooi et al., 2017; Wang et al., 2019).”
BackgroundA Guide for Calculating Study-Level Statistical Power for Meta-Analyses
Quintana, D. S. (2023) · Advances in Methods and Practices in Psychological Science · doi:10.1177/25152459221147260 · Cited by 95
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“SinceOT is being explored as a therapeutic agent in human disorders affecting social behavior and cognition, such as social anxiety and ASD (Alvares et al., 2017; Guastella et al., 2009; Ooi et al., 2017), these findings are crucial to consider.”
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“This focus may reflect efforts to explore its putative role in the physiopathology of these disorders in order to inform their suggested use as an adjunctive targeted pharmacological treatment (namely in ASD, where the vast majority of preliminary clinical trials of intranasal OT have been performed (Ooi et al., 2017).”
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“Most of these studies have focused on patients with schizophrenia (Zheng et al., 2019) and autism spectrum disorders (ASD) (Ooi et al., 2017).”
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“However, while initial single-dose administration studies yielded promising acute effects of oxytocin on pro-social behaviour 2 , subsequent multi-ple-dose, chronic administration studies (i.e. administrating the oxytocin nasal spray over a course of multiple weeks) have yielded a more mixed…”
Audunsdottir, K., Sartorius, A. M., Kang, H., Glaser, B. D., Bøen, R., Nærland, T., Alaerts, K., Kildal, E. S.-M., Westlye, L. T., Andreassen, O. A., et al. (2024) · Psychoneuroendocrinology · doi:10.1016/j.psyneuen.2024.107067 · Cited by 43
“While several previous meta-analyses have not reported evidence of publication bias (e.g., Wang et al., 2019; Ooi et al., 2016), these studies have used tools that evaluate small study bias , which can include publication bias but also capture other types of bias associated with small studies.”
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“Ooi and colleagues performed a thorough meta-analysis and reviewed existing publications and given the mixed findings from clinical trials, they came to the conclusion that the effectiveness of OT treatment for ASD should be considered tentative [32].”
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“However, in recent years, intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for elevating the core social problems characteristic of ASD (see recent review of IN-OT studies in ASD [1]).”
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“Studies on the role of ω-3 PUFAs in autism specific disorder have yielded contradictory results [84–87].”
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“In addition, individuals with ASD may vary in the functionality of their endogenous OT system and it remains likely that clinically significant responses can only be observed within particular ASD subgroups that are more genetically prone to dysfunctions in OT signaling (Ooi et al., 2016).”
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“Numerous studies on animal models and groups of healthy individuals point to the potential role of oxytocinergic and vasopresynergic systems in normal social functioning (14, 20).”
BackgroundClinical potential of oxytocin in autism spectrum disorder: current issues and future perspectives
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“significant effect on primary endpoints (Anagnostou et al., 2012; Guastella et al., 2015; Munesue et al., 2016; Ooi et al., 2017), which may be because of a lack of reliable measures for longitudinal changes in core ASD symptoms.”
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“…demonstrated behavioral improvements on various social tasks, including tasks assessing affective speech comprehension (emotional intonations) [2, 3], emotion recognition [4, 5], repetitive behavior [6], and social decision-making (cyberball computer game) [7] (for a review, see e.g., [8]).”
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“However, continuous administration of OT has some contradictory results in the literature (Ooi et al., 2017), with some showing no significant effects of OT on primary measures (Anagnostou et al.”
BackgroundOxytocin enhances neural approach towards social and non-social stimuli of high personal relevance
Alaerts, K., Taillieu, A., Daniëls, N., Soriano, J. R., & Prinsen, J. (2021) · Scientific Reports · doi:10.1038/s41598-021-02914-8 · Cited by 21
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“Oxytocin deserves a special mention because initial studies have shown oxytocin to be promising, but recent meta-analyses 17 have analyzed 12 RCTs on oxytocin and social cognition and on RRBI and found no significant effects of oxytocin on these two core symptoms.”
BackgroundOxytocin Regulates Synaptic Transmission in the Sensory Cortices in a Developmentally Dynamic Manner
Zhang, J., Li, S.-J., Miao, W., Zhang, X., Zheng, J.-J., Wang, C., & Yu, X. (2021) · Frontiers in Cellular Neuroscience · doi:10.3389/fncel.2021.673439 · Cited by 12
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“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,…”
BackgroundMethodInfluentialHarris, J. C., & Coyle, J. T. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-85654-6.00016-2 · Cited by 11
Placebo Effects in the Neuroendocrine System: Conditioning of the Oxytocin Responses
Skvortsova, A., Veldhuijzen, D. S., Pacheco‐López, G., Bakermans‐Kranenburg, M. J., van IJzendoorn, M. H., Smeets, M. A. M., Wilderjans, T. F., Dahan, A., den Bergh, O. V., Chavannes, N. H., et al. (2019) · Psychosomatic Medicine · doi:10.1097/psy.0000000000000759 · Cited by 10
Haaf, R., Brandi, M., Albantakis, L., Lahnakoski, J. M., Henco, L., & Schilbach, L. (2024) · Scientific Reports · doi:10.1038/s41598-023-50770-5 · Cited by 8
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
“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
Cicekliyurt, M. M., & DERMENCİ, B. (2022) · Revista Portuguesa de Cardiologia · doi:10.1016/j.repc.2021.06.028 · Cited by 6
Borie, A. M., Dromard, Y., Chakraborty, P., Fontanaud, P., André, E. M., François, A., Colson, P. H., Muscatelli, F., Guillon, G., Desarménien, M. G., et al. (2024) · Cell Reports Medicine · doi:10.1016/j.xcrm.2024.101781 · Cited by 6
“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
Chang, C., Liu, T., Hsiao, R. C.-J., Yang, P., Chen, Y., & Yen, C. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph18083972 · Cited by 5
“Oxytocin, an essential hormone in social behaviors [37], may assist in the treatment of the core symptoms of ASD [38].”
BackgroundLai, M., Anagnostou, E. A., Wiznitzer, M., Allison, C. L., & Baron‐Cohen, S. (2018) · OSF Preprints (OSF Preprints) · doi:10.31219/osf.io/8z5rv · Cited by 6
Zhang, Y., Zhang, X., & Huang, L. (2025) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1477076 · Cited by 5
Sex Differences in Neurodevelopment and Its Disorders
Brown, R. E. (2023) · Springer eBooks · doi:10.1007/978-3-031-20792-1_11 · Cited by 4
Heralding a new era of oxytocinergic research: New tools, new problems?
Althammer, F. (2023) · Journal of Neuroendocrinology · doi:10.1111/jne.13333 · Cited by 4
Pérez-Arqueros, V., Soler, J., Schmidt, C., Vega, D., & Pascual, J. C. (2024) · Psychoneuroendocrinology · doi:10.1016/j.psyneuen.2024.107206 · Cited by 5
Wilczyński, K. M., Stasik, A., Cichoń, L., Auguściak-Duma, A., & Janas-Kozik, M. H. (2023) · Brain Sciences · doi:10.3390/brainsci13040689 · Cited by 3
“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
“However, oxytocin has no effects on social recognition and stereotype behavior in meta-analysis [33].”
BackgroundBurmester, V., Sheridan, E., Julius, N., Elliott, J., Thackeray, O., & Nicholls, D. (2025) · European Eating Disorders Review · doi:10.1002/erv.3167 · Cited by 4
“…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
Kang, E., McDonald, R. G., & White, S. W. (2022) · Elsevier eBooks · doi:10.1016/b978-0-12-816393-1.00004-x · Cited by 3
Dissecting social decision-making: A spotlight on oxytocinergic transmission
Coccia, G., Greca, F. L., Luca, M. D., & Scheggia, D. (2022) · Frontiers in Molecular Neuroscience · doi:10.3389/fnmol.2022.1061934 · Cited by 3
“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?
Naguy, A., & Alamiri, B. (2018) · The Journal of Nervous and Mental Disease · doi:10.1097/nmd.0000000000000836 · Cited by 3
Clinical convergence of autism, schizophrenia, and Alzheimer’s disease: The case of social cognition
Levine, J. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-814037-6.00002-1 · Cited by 3
(2021) · Wiley eBooks · doi:10.1002/9781119870203.mpg005 · Cited by 3
Patwardhan, A., Li, S., Chen, J. A., & Choe, K. Y. (2025) · Journal of Neuroendocrinology · doi:10.1111/jne.70092 · Cited by 2
Chauhan, N. B., Kale, M., & Naik, N. (2022) · MedPress Neurology and Neurosurgery · doi:10.33582/mpnns.2022.202201002 · Cited by 2
Yılmazer, E., Çınaroğlu, M., Köse, S. K., Ülker, S. V., & Tarlacı, S. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14196760 · Cited by 2
“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].”
Metadata
- 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
- FWCI
- 1.88
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pharmacopsychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Science Foundation
- Topics
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › 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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