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Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial
Open accessAbstract
BACKGROUND: There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors. METHODS: This was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale - compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire - emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses. RESULTS: Although no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire - emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported. CONCLUSIONS: This pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted. TRIAL REGISTRATION: NCT00490802.
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In the citing paper
“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 [21]
In the citing paper
“Multiple lines of evidence suggest an involvement of dysregulated neurotransmitter systems (serotonergic, oxytocinergic and dopaminergic systems) in autism.”
From Vitamin D and Autism Spectrum Disorder: A Literature Review (2016) · cites this paper as [181]
In the citing paper
“These systems play key roles in neurotransmission, brain maturation, cortical organisation and behaviours (including social behaviour and repetitive behaviour) [180,181,182,183,184].”
From Vitamin D and Autism Spectrum Disorder: A Literature Review (2016) · cites this paper as [181]
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 [6]
In the citing paper
“This route of administration has been validated for both OT (6, 71) and NAL (72–74) in previous human studies”
From Oxytocin under opioid antagonism leads to supralinear enhancement of social attention (2017) · cites this paper as [6]
In the citing paper
“Clinical trials examining core symptoms of ASD have failed to consistently demonstrate efficacy of intranasal OT treatment (Anagnostou et al., 2012; Dadds et al., 2014; Guastella et al., 2015; Hollander et al., 2007)”
From Parallel social information processing circuits are differentially impacted in autism (2020) · cites this paper as Anagnostou et al., 2012
In the citing paper
“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 [75]
In the citing paper
“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 [75]
In the citing paper
“For example, oxytocin has been shown to increase gazing time on the eye region33, and to improve performance on the Reading the Mind in the Eyes Task in adults and adolescents with ASD48,49.”
From Randomized clinical trial shows no substantial modulation of empathy-related neural activation by intranasal oxytocin in autism (2021) · cites this paper as [49]
In the citing paper
“This pilot study suggested therapeutic potential with daily administration of IN-OT in this population of adults with ASD. This six-week study noted improvements in social cognition, quality of life, RRB, and some measures of emotional well-being with IN-OT, in essence, improvement in the core domains of ASD.”
From Oxytocin and vasopressin systems in genetic syndromes and neurodevelopmental disorders (2014) · cites this paper as Anagnostou et al., 2012
In the citing paper
“Taken together, findings of these initial multiple-dose trials provided indications for a more consistent (positive) pattern of results for OT trials with adults with ASD [8–10], compared to trials with children with ASD [11–14].”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“Anagnostou et al. [8] assessed the safety and efficacy of 6 weeks of intranasal OT treatment on core autism symptom domains (social cognition/function and repetitive behaviors) in 19 adults with ASD (16 men, three women), and showed improved emotion recognition, quality of life, and tentative improvements in repetitive behaviors after OT treatment.”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“The initial sample size (n = 40) was set to be comparable to three prior studies showing significant effects of multiple-dose OT treatment on similar outcome measures [8, 9, 17].”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“In this view, it appears that beneficial effects of OT treatment on repetitive behaviors were mostly demonstrated in studies that adopted assessments based on self-reports (current study, [4, 8]), whereas no beneficial effects were evident in studies adopting informant-based reports of repetitive behavior [9–14].”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“Overall, these observed effects on repetitive behaviors are in line with previous trials with adult men with ASD showing beneficial effects of OT on repetitive behaviors after 4 h of intravenous OT administration [4] and after 6 weeks of daily administrations [8, 10].”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“Contrary to our findings, Anagnostou et al. [8] reported an OT-specific improvement in quality of life (socio-emotional section) after a 6-week treatment in adult men with ASD.”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“Second, in the current study, participants administered the OT nasal spray once a day (in the morning) while the majority of prior multiple-dose OT studies administered two doses/day (one in the morning and one in the afternoon) ([8–10, 12–14], but see [11]).”
From Behavioral effects of multiple-dose oxytocin treatment in autism: a randomized, placebo-controlled trial with long-term follow-up (2020) · cites this paper as [8]
In the citing paper
“Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD)”
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Metadata
- Authors
- Anagnostou, E., Soorya, L., Chaplin, W., Bartz, J., Halpern, D., Wasserman, S., Wang, A. T., Pepa, L., Tanel, N., Kushki, A., & Hollander, E.
- Affiliations
- University of Toronto (CA)
- Rush University (US)
- St. John's University (US)
- Icahn School of Medicine at Mount Sinai (US)
- Albert Einstein College of Medicine (US)
- Corresponding author
- Anagnostou, Evdokia
- ORCID
- Venue
- Molecular Autism
- Published
- 2012
- Volume
- 3
- Issue
- 1
- Pages
- 16
- ISSN
- 2040-2392 (ISSN-L)
- PMC
- PMC3539865
- OpenAlex
- W2134806674
- Cited by
- 350
- References
- 40
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 18 · 2023: 22 · 2022: 24 · 2021: 22 · 2020: 33 · 2019: 23 · 2018: 25 · 2017: 38 · 2016: 31 · 2015: 32 · 2014: 33 · 2013: 26 · 2012: 1
- FWCI
- 44.40
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Molecular Autism (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- TSpace (University of Toronto) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- U.S. Department of Defense
- Ontario Brain Institute
- National Alliance for Research on Schizophrenia and Depression
- Holland Bloorview Kids Rehabilitation Hospital Foundation
- National Institutes of Health
- Canadian Institutes of Health Research
- 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
- intranasal oxytocin, autism spectrum disorder, autistic adults, social cognition, social functioning, repetitive behavior, quality of life, Reading the Mind in the Eyes Test, Yale-Brown Obsessive Compulsive Scale, drug safety
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