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        Hormone widely used                                                      evidence in this large study that
                                                                                 is strong enough to justify more
        as an autism treatment                                                   investigation of oxytocin as a treatment
                                                                                 for autism spectrum disorders.”
        shows no benefit                                                         In addition to Sikich and Veenstra-
                                                                                 VanderWeele, study authors include
                                                                                 Alexander Kolevzon, Bryan H. King,
                                                                                 Christopher J. McDougle, Kevin B.
        Multicenter study finds that oxytocin was safe,                          Sanders, Soo-Jeong Kim, Marina
        but ineffective at boosting social skills among                          Spanos, Tara Chandrasekhar, Pilar
        children with autism                                                     Trelles, Carol M. Rockhill, Michelle
                                                                                 L. Palumbo, Allyson Witters Cundiff,
                                                                                 Alicia Montgomery, Paige Siper,
               xytocin, a naturally occurring   treatment for children with Autism   Mendy Minjarez, Lisa A. Nowinski,
               hormone that acts as a        Spectrum Disorder.                  Sarah Marler, Lauren C. Shuffrey,
        Ochemical messenger in the                                               Cheryl Alderman, Jordana Weissman,
        brain, showed no evidence of helping   The research team enrolled 290    Brooke Zappone, Jennifer E. Mullett,
        children with autism gain social     children ages 3-17, stratified by   Hope Crosson, Natalie Hong,
        skills, according to a large national   age and the severity of their autism   Stephen K. Siecinski, Stephanie N.
        study appearing Oct. 13 in the New   symptoms. The children were         Giamberardino, Sheng Luo, Lilin She,
        England Journal of Medicine.         randomized in similar, equal-sized   Manjushri Bhapkar, Russell Dean and
                                             groups to receive oxytocin or a     Abby Scheer.
        While disappointing for those holding   placebo via a daily nasal spray
        hope that oxytocin could benefit     over 24 weeks.                      The study received funding from the
        children with autism, the long-awaited                                   Eunice Kennedy Shriver National
        finding provides clarity for a drug   The study aimed to see if the      Institute of Child Health and Human
        that has shown mixed outcomes in     regimen of oxytocin would have a    Development (U01HD073984)
        smaller, less robust studies.        measurable impact on the children’s   and the National Center for
                                             social abilities based on screenings   Advancing Translational Sciences
        “There was a great deal of hope      and assessments at the start of the   (UL1TR002489).
        this drug would be effective,” said   trial, midway through and at the end.
        the study’s principal investigator   Both researchers and the children’s   Story Source:
        and lead author, Linmarie Sikich,    parents provided assessments using   Materials provided by Duke University
        M.D., associate consulting professor   standard analytic tools for autism.  Medical Center. Note: Content may be
        in the Department of Psychiatry                                          edited for style and length.
        & Behavioral Sciences at Duke        While the oxytocin was well
        University School of Medicine. “All   tolerated and had few side effects,   Journal Reference:
        of us on the study team were hugely   it showed no significant benefit   1. Linmarie Sikich, Alexander
        disappointed, but oxytocin does not   among the group of children who    Kolevzon, Bryan H. King, Christopher
        appear to change social function of   received it compared to those who   J. McDougle, Kevin B. Sanders,
        people with autism.”                 received the placebo.               Soo-Jeong Kim, Marina Spanos,
                                                                                 Tara Chandrasekhar, M.D. Pilar
        Oxytocin is typically used to induce   “Thousands of children with autism   Trelles, Carol M. Rockhill, Michelle
        labor, but because of its activity in   spectrum disorder were prescribed   L. Palumbo, Allyson Witters Cundiff,
        the brain, it has been investigated as   intranasal oxytocin before it was   Alicia Montgomery, Paige Siper,
        a treatment for autism. Evidence has   adequately tested,” Veenstra-     Mendy Minjarez, Lisa A. Nowinski,
        been conflicting, with several smaller   VanderWeele said. “Thankfully,   Sarah Marler, Lauren C. Shuffrey,
        studies suggesting it improved social   our data show that it is safe.   Cheryl Alderman, Jordana Weissman,
        and cognitive function among some    Unfortunately, it is no better than   Brooke Zappone, Jennifer E. Mullett,
        children with autism, while other    placebo when used daily for months.   Hope Crosson, Natalie Hong,
        studies showed no benefit.           These results indicate that clinicians   Stephen K. Siecinski, Stephanie N.
                                             and families should insist that there   Giamberardino, Sheng Luo, Lilin She,
        Sikich and colleagues, including     is strong evidence for the safety and   Manjushri Bhapkar, Russell Dean,
        senior author Jeremy Veenstra-       benefit of new treatments before they   Abby Scheer, Jacqueline L. Johnson,
        VanderWeele, M.D., of New York       are provided to patients in the clinic.”  Simon G. Gregory, Jeremy Veenstra-
        State Psychiatric Institute and                                          VanderWeele. Intranasal Oxytocin in
        Columbia University, designed        Sikich said no further study is likely   Children and Adolescents with Autism
        the multi-site trial to provide the   of oxytocin, given the negative    Spectrum Disorder. New England
        best evidence yet about whether      findings: “Our consensus as         Journal of Medicine, 2021; 385 (16):
        oxytocin was a safe and effective    investigators is that there is no   1462 DOI: 10.1056/NEJMoa2103583

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