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The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial
Open accessAbstract
Interventions for autism are limited. The synthetic hormone oxytocin may provide a potential treatment to improve core social and behavioral difficulties in autism, but its efficacy has yet to be evaluated in young children who potentially may benefit to a greater extent. We investigated the efficacy, tolerability and safety of oxytocin treatment in young children with autism using a double-blind, randomized, placebo-controlled, crossover, clinical trial. Thirty-one children with autism received 12 International Units (IU) of oxytocin and placebo nasal spray morning and night (24 IU per day) for 5 weeks, with a 4-week washout period between each treatment. Compared with placebo, oxytocin led to significant improvements on the primary outcome of caregiver-rated social responsiveness. Overall, nasal spray was well tolerated, and the most common reported adverse events were thirst, urination and constipation. This study is the first clinical trial to support the potential of oxytocin as an early intervention for young children with autism to help improve social interaction deficits.
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In the citing paper
“Oxytocin has received substantial interest as a potential treatment for psychiatric conditions such as autism spectrum conditions (ASC; henceforth autism),3 although clinical trials show modest effects.4, 5, 6”
From Intranasal oxytocin enhances intrinsic corticostriatal functional connectivity in women (2017) · cites this paper as [6]
In the citing paper
“Clinical trials of OT in autistic patients are ongoing, yet several studies have produced inconclusive results (4–8)”
From Oxytocin under opioid antagonism leads to supralinear enhancement of social attention (2017) · cites this paper as [5]
In the citing paper
“OT has been used safely with chronic administration in recent clinical trials (5)”
From Oxytocin under opioid antagonism leads to supralinear enhancement of social attention (2017) · cites this paper as [5]
In the citing paper
“Results of OXT studies in children have overall been more equivocal with mixed results.”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [81]
In the citing paper
“Although 4 studies showed positive short-term results of OXT administration on social responsiveness (following 4 or 5 weeks of OXT administration) [80–83]”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [81]
In the citing paper
“In another subsequent study from the same group, researchers found significant improvements on SRS outcome following chronic administration of IN-OT in children with ASD using a cross-over clinical trial design (Yatawara et al. 2016).”
From A precision medicine approach to oxytocin trials (2017) · cites this paper as Yatawara et al. 2016
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Oxytocin in neurodevelopmental disorders: Autism spectrum disorder and Prader-Willi syndrome
Josselsohn, A., Zhao, Y., Espinoza, D., & Hollander, E. (2024) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2024.108734 · Cited by 16
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Oxytocin Receptor in Cerebellar Purkinje Cells Does Not Engage in Autism-Related Behaviors
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No side-effects of single intranasal oxytocin administration in middle childhood
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Targeted Biomedical Treatment for Autism Spectrum Disorders
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Available Treatments for Autism Spectrum Disorder: From Old Strategies to New Options
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Self-citationIntranasal Oxytocin Failed to Affect Chimpanzee (Pan troglodytes) Social Behavior
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Involvement of oxytocin receptor deficiency in psychiatric disorders and behavioral abnormalities
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Metadata
- Authors
- Yatawara, C. J., Einfeld, S. L., Hickie, I. B., Davenport, T. A., & Guastella, A. J.
- Affiliations
- The University of Sydney (AU)
- Corresponding author
- Guastella, A J
- Venue
- Molecular Psychiatry
- Published
- 2015-10-27
- Volume
- 21
- Issue
- 9
- Pages
- 1225-1231
- ISSN
- 1359-4184 (ISSN-L)
- 1476-5578
- PMC
- PMC4995545
- OpenAlex
- W1823169087
- Cited by
- 344
- References
- 43
- Citations by year
- 2026: 18 · 2025: 18 · 2024: 27 · 2023: 21 · 2022: 38 · 2021: 26 · 2020: 34 · 2019: 36 · 2018: 41 · 2017: 44 · 2016: 37 · 2015: 4
- FWCI
- 68.73
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Molecular Psychiatry (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- National Health and Medical Research Council (APP 511921, 511921, 623625, 1043664, 1061922)
- 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, young children, nasal spray, social interaction deficits, social responsiveness, early intervention, treatment tolerability, adverse events
- MeSH terms
- Autism Spectrum Disorder, Administration, Intranasal, Autistic Disorder, Child, Child, Preschool, Double-Blind Method, Female, Humans, Interpersonal Relations, Male, Oxytocin, Social Behavior, Treatment Outcome, Cross-Over Studies, Nasal Sprays
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