Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.

Sikich, Linmarie; Kolevzon, Alexander; King, Bryan H; McDougle, Christopher J; Sanders, Kevin B; Kim, Soo-Jeong; Spanos, Marina; Chandrasekhar, Tara; Trelles, MD Pilar; Rockhill, Carol M; Palumbo, Michelle L; Witters Cundiff, Allyson; Montgomery, Alicia; Siper, Paige; Minjarez, Mendy; Nowinski, Lisa A; Marler, Sarah; Shuffrey, Lauren C; Alderman, Cheryl; Weissman, Jordana; Zappone, Brooke; Mullett, Jennifer E; Crosson, Hope; Hong, Natalie; Siecinski, Stephen K; Giamberardino, Stephanie N; Luo, Sheng; She, Lilin; Bhapkar, Manjushri; Dean, Russell; Scheer, Abby; Johnson, Jacqueline L; Gregory, Simon G; Veenstra-VanderWeele, Jeremy

Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.

dc.contributor.author	Sikich, Linmarie
dc.contributor.author	Kolevzon, Alexander
dc.contributor.author	King, Bryan H
dc.contributor.author	McDougle, Christopher J
dc.contributor.author	Sanders, Kevin B
dc.contributor.author	Kim, Soo-Jeong
dc.contributor.author	Spanos, Marina
dc.contributor.author	Chandrasekhar, Tara
dc.contributor.author	Trelles, MD Pilar
dc.contributor.author	Rockhill, Carol M
dc.contributor.author	Palumbo, Michelle L
dc.contributor.author	Witters Cundiff, Allyson
dc.contributor.author	Montgomery, Alicia
dc.contributor.author	Siper, Paige
dc.contributor.author	Minjarez, Mendy
dc.contributor.author	Nowinski, Lisa A
dc.contributor.author	Marler, Sarah
dc.contributor.author	Shuffrey, Lauren C
dc.contributor.author	Alderman, Cheryl
dc.contributor.author	Weissman, Jordana
dc.contributor.author	Zappone, Brooke
dc.contributor.author	Mullett, Jennifer E
dc.contributor.author	Crosson, Hope
dc.contributor.author	Hong, Natalie
dc.contributor.author	Siecinski, Stephen K
dc.contributor.author	Giamberardino, Stephanie N
dc.contributor.author	Luo, Sheng
dc.contributor.author	She, Lilin
dc.contributor.author	Bhapkar, Manjushri
dc.contributor.author	Dean, Russell
dc.contributor.author	Scheer, Abby
dc.contributor.author	Johnson, Jacqueline L
dc.contributor.author	Gregory, Simon G
dc.contributor.author	Veenstra-VanderWeele, Jeremy
dc.date.accessioned	2021-11-01T15:09:35Z
dc.date.available	2021-11-01T15:09:35Z
dc.date.issued	2021-10
dc.date.updated	2021-11-01T15:09:34Z
dc.description.abstract	Background Experimental studies and small clinical trials have suggested that treatment with intranasal oxytocin may reduce social impairment in persons with autism spectrum disorder. Oxytocin has been administered in clinical practice to many children with autism spectrum disorder. Methods We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder. Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily. The primary outcome was the least-squares mean change from baseline on the Aberrant Behavior Checklist modified Social Withdrawal subscale (ABC-mSW), which includes 13 items (scores range from 0 to 39, with higher scores indicating less social interaction). Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ. Results Of the 355 children and adolescents who underwent screening, 290 were enrolled. A total of 146 participants were assigned to the oxytocin group and 144 to the placebo group; 139 and 138 participants, respectively, completed both the baseline and at least one postbaseline ABC-mSW assessments and were included in the modified intention-to-treat analyses. The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P = 0.61). Secondary outcomes generally did not differ between the trial groups. The incidence and severity of adverse events were similar in the two groups. Conclusions This placebo-controlled trial of intranasal oxytocin therapy in children and adolescents with autism spectrum disorder showed no significant between-group differences in the least-squares mean change from baseline on measures of social or cognitive functioning over a period of 24 weeks. (Funded by the National Institute of Child Health and Human Development; SOARS-B ClinicalTrials.gov number, NCT01944046.).
dc.identifier.issn	0028-4793
dc.identifier.issn	1533-4406
dc.identifier.uri	https://hdl.handle.net/10161/23953
dc.language	eng
dc.publisher	Massachusetts Medical Society
dc.relation.ispartof	The New England journal of medicine
dc.relation.isversionof	10.1056/nejmoa2103583
dc.title	Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.
dc.type	Journal article
duke.contributor.orcid	Chandrasekhar, Tara\|0000-0001-5043-4286
duke.contributor.orcid	Luo, Sheng\|0000-0003-4214-5809
duke.contributor.orcid	Bhapkar, Manjushri\|0000-0001-5388-600X
duke.contributor.orcid	Gregory, Simon G\|0000-0002-7805-1743
pubs.begin-page	1462
pubs.end-page	1473
pubs.issue	16
pubs.organisational-group	School of Medicine
pubs.organisational-group	Duke
pubs.organisational-group	Duke Clinical Research Institute
pubs.organisational-group	Biostatistics & Bioinformatics
pubs.organisational-group	Institutes and Centers
pubs.organisational-group	Basic Science Departments
pubs.publication-status	Published
pubs.volume	385