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Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.

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Date
2021-10
Authors
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
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Abstract
<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.).
Type
Journal article
Permalink
https://hdl.handle.net/10161/23953
Published Version (Please cite this version)
10.1056/nejmoa2103583
Publication Info
Sikich, Linmarie; Kolevzon, Alexander; King, Bryan H; McDougle, Christopher J; Sanders, Kevin B; Kim, Soo-Jeong; ... Veenstra-VanderWeele, Jeremy (2021). Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder. The New England journal of medicine, 385(16). pp. 1462-1473. 10.1056/nejmoa2103583. Retrieved from https://hdl.handle.net/10161/23953.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Chandrasekhar

Tara Chandrasekhar

Assistant Professor of Psychiatry and Behavioral Sciences
Duke Autism Clinic
Gregory

Simon Gray Gregory

Professor in Neurosurgery
Dr. Gregory is a tenured Professor and Director of the Brain Tumor Omics Program (BTOP) in the Duke Department of Neurosurgery, the Vice Chair of Research in the Department of Neurology, and Director of the Molecular Genomics Core at the Duke Molecular Physiology Institute.  As a neurogenomicist, Dr. Gregory applies the experience gained from leading the sequencing of chromosome 1 for the Human Genome Project to elucidating the mechanisms underlying multi-factorial
Luo

Sheng Luo

Professor of Biostatistics & Bioinformatics
Alphabetical list of authors with Scholars@Duke profiles.
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