A large clinical trial will test the safety and effectiveness of oxytocin nasal spray to improve sociability and communication in children and teens with autism. The federally funded clinical trial follows the promising results of a pilot study funded by Autism Speaks. The researchers hope to recruit 300 participants, ages 3 to 17, at centers in Boston, New York, Seattle, Nashville and North Carolina.
A naturally occurring hormone, oxytocin plays a critical role in sociability and affiliation. In the Autism Speaks-funded pilot study, researchers administered oxytocin or saline nasal spray to 25 children and teens twice a day for 2 months. The children who received oxytocin showed greater improvement in social behaviors compared to those who received the inactive nasal spray. Based in part on these promising results, the National Institutes of Health (NIH) awarded $12.6 million to fund a national clinical trial.
“The Autism Speaks-funded pilot study was critical in getting the larger grant to test this treatment,” says lead researcher Linmarie Sikich, M.D., of the University of North Carolina, Chapel Hill. “We want to extend our great appreciation to Autism Speaks, the families and children who participated in the pilot study and the National Institute of Child Health and Human Development, which is supporting the larger trial.”
The study is called SOARS-B, for the Study of Oxytocin in Autism to improve Reciprocal Social Behaviors. During the first six months of the study, half of the participants will receive the oxytocin spray. The other half will receive the saline spray, for comparison. Neither researchers nor participants will know who receives which. During a second six-month period, all participants will receive the oxytocin spray.
The researchers will measure improvements in social skills and communication. They will also use blood samples to conduct gene-based tests. In this way, they hope to track whether and how the treatment alters gene activity associated with sociability.
“This exemplifies translational science,” says Autism Speaks Chief Science Officer Geri Dawson, Ph.D. “Autism Speaks funding of basic science on oxytocin and a pilot clinical trial with children provided the leverage needed to fund a gold-standard national trial. We’re tremendously grateful to our donors for making this possible.”
The researchers expect to start enrolling subjects in early 2013. Participating centers include:
* The University of North Carolina ASPIRE program, in Chapel Hill and Durham
* The Lurie Center for Autism, Massachusetts General Hospital, Boston
* Seaver Autism Center, Mount Sinai School of Medicine, New York
* Seattle Children’s Research Institute
* The Vanderbilt Treatment and Research Institute for Autism Spectrum Disorders, Nashville
For more information, visit the SOARS website. Please also see Autism Speak Participants Guide to Autism Drug Research.
Funding of the SOARS study is part of $100 million in federal grants awarded to nine Autism Centers of Excellence earlier this month. Many of these major research projects grew out of pilot studies funded by Autism Speaks. Please see our related news story here.
Reported by Autism Speaks science writer Laurie Tarkan