Dr. Christopher J. McDougle at work at the Lurie Center for Autism
The Lurie Center for Autism at MassGeneral Hospital for Children will take part in a $12.6 million 5-year study of the effectiveness of using intranasal oxytocin – a hormone believed to be important in the formation of social bonds – to treat impaired social relatedness in children and teenagers with autism spectrum disorders.
The study is funded by a grant from the National Institutes of Health's Autism Centers of Excellence (ACE) research program. The grant was awarded to researcher Linmarie Sikich, MD of the ASPIRE Research Program at the University of North Carolina-Chapel Hill, who will lead the study for the ACE SOARS Network. While the study is based at UNC-Chapel Hill, this research will take place in network sites at the Lurie Center, the Mount Sinai School of Medicine, Vanderbilt University, and the Seattle Children’s Research Institute.
“There’s never been a medication shown to consistently help the core impaired social relatedness in autism spectrum disorders,” says Christopher J. McDougle, MD, director of the Lurie Center. “This will be the largest drug study ever done in autism, and we’re excited to be a part of it.”
Impaired social relatedness – a lack of non-verbal communication and empathy and a failure to develop age-appropriate peer relationships – is a core feature of autism spectrum disorders. While the drugs Risperdal and Abilify have been effective in reducing autism-associated behaviors like irritability, neither drug adequately addresses the core features of autism.
Oxytocin is the brain’s most abundant hormone. Widely used in the United States to induce labor and to stimulate breastfeeding, it also is thought to be important in mother/infant bonding and in other social relationships. In animal studies, oxytocin has been shown to increase eye contact, social interaction and sharing and to reduce stress responses. A few human trials in autism spectrum disorders had promising results, but those studies were small and used only a single dose of intranasal oxytocin.
The new study, called the Study of Oxytocin in Autism to improve Reciprocal Social Behaviors (SOARS-B), will last five years and enroll 300 children and adolescents (ages 3-17 years) with an autism spectrum disorder diagnosis. Each of the five network ACE programs will recruit patients, who will be randomly assigned to receive either intranasal oxytocin or a placebo nasal spray for the first six months. Then all participants will receive the intranasal oxytocin for an additional six months. Enrollment is expected to begin in early 2013.
McDougle says the study’s broad approach – focusing equally on a variety of subsets within the autism spectrum, including verbal and nonverbal individuals – makes it unique.