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While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development\u00a0in humans remains unclear. We investigated the efficacy, tolerability, and safety of intranasal oxytocin in young children with autism using a double-blind, randomized, placebo-controlled, clinical trial, following a placebo lead-in phase. A total of 87 children (aged between 3 and 12 years) with autism received 16 International Units (IU) of oxytocin (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200945) or placebo (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200942) nasal spray, morning and night (32 IU per day) for twelve weeks, following a 3-week placebo lead-in phase. Overall, there was no effect of oxytocin treatment over time on the caregiver-rated Social Responsiveness Scale (SRS-2) (\n                    <jats:italic>p<\/jats:italic>\n                    \u2009=\u20090.686). However, a significant interaction with age (\n                    <jats:italic>p<\/jats:italic>\n                    = 0.028)\u00a0showed that for younger children, aged 3\u20135 years, there was some indication of a treatment effect. Younger children who received oxytocin showed improvement on\u00a0caregiver-rated social responsiveness (\u00a0SRS-2). There was no other evidence of benefit in the sample as a whole, or in the younger age group, on the clinician-rated Clinical Global Improvement Scale (CGI-S), or any secondary measure. Importantly, placebo effects in the lead-in phase were evident\u00a0and there was support for washout of the placebo response in the randomised phase. Oxytocin was well tolerated, with more adverse side effects reported in the placebo group. This study suggests the need for further clinical trials\u00a0to test\u00a0the benefits of oxytocin treatment in younger populations with autism.\n                  <\/jats:p>\n                  <jats:p>\n                    Trial registration\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.anzctr.org.au\">www.anzctr.org.au<\/jats:ext-link>\n                    (ACTRN12617000441314).\n                  <\/jats:p>","DOI":"10.1038\/s41380-022-01845-8","type":"journal-article","created":{"date-parts":[[2022,10,27]],"date-time":"2022-10-27T03:02:49Z","timestamp":1666839769000},"page":"834-842","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":73,"title":["The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial"],"prefix":"10.1038","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8178-4625","authenticated-orcid":false,"given":"Adam J.","family":"Guastella","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelsie A.","family":"Boulton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J. 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He has not received personal financial benefits from this contracted work. Professor Ian Hickie was an inaugural Commissioner on Australia\u2019s National Mental Health Commission (2012-18). He is the Co-Director, Health and Policy at the Brain and Mind Center (BMC) University of Sydney, Australia. The BMC operates an early-intervention youth services at Camperdown under contract to headspace. Professor Hickie has previously led community-based and pharmaceutical industry-supported (Wyeth, Eli Lily, Servier, Pfizer, AstraZeneca) projects focused on the identification and better management of anxiety and depression. He was a member of the Medical Advisory Panel for Medibank Private until October 2017, a Board Member of Psychosis Australia Trust and a member of Veterans Mental Health Clinical Reference group. He is the Chief Scientific Advisor to, and a 5% equity shareholder in, InnoWell Pty Ltd. InnoWell was formed by the University of Sydney (45% equity) and PwC (Australia; 45% equity) to deliver the $30\u2009M Australian Government-funded Project Synergy (2017- 20; a three-year program for the transformation of mental health services) and to lead transformation of mental health services internationally through the use of innovative technologies.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}