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Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder. 2021
Linmarie Sikich, and
Alexander Kolevzon, and
Bryan H King, and
Christopher J McDougle, and
Kevin B Sanders, and
Soo-Jeong Kim, and
Marina Spanos, and
Tara Chandrasekhar, and
M D Pilar Trelles, and
Carol M Rockhill, and
Michelle L Palumbo, and
Allyson Witters Cundiff, and
Alicia Montgomery, and
Paige Siper, and
Mendy Minjarez, and
Lisa A Nowinski, and
Sarah Marler, and
Lauren C Shuffrey, and
Cheryl Alderman, and
Jordana Weissman, and
Brooke Zappone, and
Jennifer E Mullett, and
Hope Crosson, and
Natalie Hong, and
Stephen K Siecinski, and
Stephanie N Giamberardino, and
Sheng Luo, and
Lilin She, and
Manjushri Bhapkar, and
Russell Dean, and
Abby Scheer, and
Jacqueline L Johnson, and
Simon G Gregory, and
Jeremy Veenstra-VanderWeele
From the Department of Psychiatry and Behavioral Sciences (L. Sikich, M.S., T.C., C.A., A.S.), the Duke Clinical Research Institute (L. Sikich, C.A., S.L., L. She, M.B.), the Duke Molecular Physiology Institute (S.K.S., S.N.G., S.G.G.), and the Departments of Biostatistics and Bioinformatics (S.L.) and Neurology (S.G.G.), Duke University, Durham, the Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill (L. Sikich, M.S., T.C., C.A., R.D., A.S., J.L.J.), and SAS Institute, Cary (J.L.J.) - all in North Carolina; the Department of Psychiatry, Icahn School of Medicine at Mount Sinai (A.K., M.D.P.T., P.S., J.W.), the Department of Psychiatry, Columbia University (A.M., L.C.S., N.H., J.V.-V.), and New York State Psychiatric Institute (J.V.-V.), New York, and the Center for Autism and the Developing Brain, Weill Cornell Medicine, White Plains (J.V.-V.) - all in New York; the Department of Psychiatry, University of California San Francisco, San Francisco (B.H.K.); the Department of Psychiatry, Seattle Children's Hospital and the University of Washington, Seattle (B.H.K., S.-J.K., C.M.R., M.M., B.Z.); the Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston (C.J.M., M.L.P., L.A.N., J.E.M.), and the Lurie Center for Autism, Lexington (C.J.M., M.L.P., L.A.N., J.E.M.) - all in Massachusetts; Hoffmann-La Roche, Basel, Switzerland (K.B.S.); the Department of Psychiatry, Vanderbilt University, Nashville (K.B.S., A.W.C., S.M., H.C.); the University of New South Wales, Sydney (A.M.); and Florida International University, Miami (N.H.).
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. 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. 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. 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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