Cargando…
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...
Autores principales: | , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1784818641802362880 |
---|---|
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). |
format | Online Article Text |
id | pubmed-9607840 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT guastellaadamj theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT boultonkelsiea theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT whitehouseandrewjo theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT songyunju theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT thaparinku theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT gregorysimong theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT pokorskiizabella theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT granichjoanna theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT demayomarilenam theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT ambarchizahava theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT wrayjohn theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT thomasemmae theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT hickieianb theeffectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT guastellaadamj effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT boultonkelsiea effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT whitehouseandrewjo effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT songyunju effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT thaparinku effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT gregorysimong effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT pokorskiizabella effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT granichjoanna effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT demayomarilenam effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT ambarchizahava effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT wrayjohn effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT thomasemmae effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial AT hickieianb effectofoxytocinnasalsprayonsocialinteractioninyoungchildrenwithautismarandomizedclinicaltrial |