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The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial

Early supports to enhance social development in children with autism are widely promoted. While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development in humans remains unclear. We investigated the efficacy, tolerability, and saf...

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Autores principales: Guastella, Adam J., Boulton, Kelsie A., Whitehouse, Andrew J. O., Song, Yun Ju, Thapa, Rinku, Gregory, Simon G., Pokorski, Izabella, Granich, Joanna, DeMayo, Marilena M., Ambarchi, Zahava, Wray, John, Thomas, Emma E., Hickie, Ian B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607840/
https://www.ncbi.nlm.nih.gov/pubmed/36302965
http://dx.doi.org/10.1038/s41380-022-01845-8
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author Guastella, Adam J.
Boulton, Kelsie A.
Whitehouse, Andrew J. O.
Song, Yun Ju
Thapa, Rinku
Gregory, Simon G.
Pokorski, Izabella
Granich, Joanna
DeMayo, Marilena M.
Ambarchi, Zahava
Wray, John
Thomas, Emma E.
Hickie, Ian B.
author_facet Guastella, Adam J.
Boulton, Kelsie A.
Whitehouse, Andrew J. O.
Song, Yun Ju
Thapa, Rinku
Gregory, Simon G.
Pokorski, Izabella
Granich, Joanna
DeMayo, Marilena M.
Ambarchi, Zahava
Wray, John
Thomas, Emma E.
Hickie, Ian B.
author_sort Guastella, Adam J.
collection PubMed
description Early supports to enhance social development in children with autism are widely promoted. While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development in 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 = 45) or placebo (n = 42) 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) (p = 0.686). However, a significant interaction with age (p = 0.028) showed that for younger children, aged 3–5 years, there was some indication of a treatment effect. Younger children who received oxytocin showed improvement on caregiver-rated social responsiveness ( SRS-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 and 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 to test the benefits of oxytocin treatment in younger populations with autism. Trial registration www.anzctr.org.au (ACTRN12617000441314).
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spelling pubmed-96078402022-10-28 The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial Guastella, Adam J. Boulton, Kelsie A. Whitehouse, Andrew J. O. Song, Yun Ju Thapa, Rinku Gregory, Simon G. Pokorski, Izabella Granich, Joanna DeMayo, Marilena M. Ambarchi, Zahava Wray, John Thomas, Emma E. Hickie, Ian B. Mol Psychiatry Article Early supports to enhance social development in children with autism are widely promoted. While oxytocin has a crucial role in mammalian social development, its potential role as a medication to enhance social development in 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 = 45) or placebo (n = 42) 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) (p = 0.686). However, a significant interaction with age (p = 0.028) showed that for younger children, aged 3–5 years, there was some indication of a treatment effect. Younger children who received oxytocin showed improvement on caregiver-rated social responsiveness ( SRS-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 and 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 to test the benefits of oxytocin treatment in younger populations with autism. Trial registration www.anzctr.org.au (ACTRN12617000441314). Nature Publishing Group UK 2022-10-27 2023 /pmc/articles/PMC9607840/ /pubmed/36302965 http://dx.doi.org/10.1038/s41380-022-01845-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Guastella, Adam J.
Boulton, Kelsie A.
Whitehouse, Andrew J. O.
Song, Yun Ju
Thapa, Rinku
Gregory, Simon G.
Pokorski, Izabella
Granich, Joanna
DeMayo, Marilena M.
Ambarchi, Zahava
Wray, John
Thomas, Emma E.
Hickie, Ian B.
The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
title The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
title_full The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
title_fullStr The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
title_full_unstemmed The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
title_short The effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
title_sort effect of oxytocin nasal spray on social interaction in young children with autism: a randomized clinical trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9607840/
https://www.ncbi.nlm.nih.gov/pubmed/36302965
http://dx.doi.org/10.1038/s41380-022-01845-8
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