Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.
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.).
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https://hdl.handle.net/10161/23953Published Version (Please cite this version)
10.1056/nejmoa2103583Publication 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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Show full item recordScholars@Duke
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
Sheng Luo
Professor of Biostatistics & Bioinformatics
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