The Lurie Center for Autism at MassGeneral Hospital for Children will take part in a $12.6 million 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 teens with autism spectrum disorders. Impaired social relatedness – a lack of nonverbal communication and empathy and a failure to develop age-appropriate peer relationships – is a core feature of autism spectrum disorders.
The study is funded by a grant from the National Institutes of Health Autism Centers of Excellence (ACE) program awarded to researcher Linmarie Sikich, MD, of the University of North Carolina-Chapel Hill. Sikich will lead the effort for the ACE Study of Oxytocin in Autism to improve Reciprocal Social Behaviors Network, coordinating research from 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 patients with 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.”
The study, expected to launch in early 2013, will last five years and enroll 300 children and teens ages 3 to 17 with an autism diagnosis. Each site will recruit patients who will be randomly assigned to receive either intranasal oxytocin or a placebo for the first six months. All participants will then receive the drug for another six months.
McDougle says the study is unique in its broad approach – focusing equally on a variety of subsets within the autism spectrum, including verbal and nonverbal individuals. This is the first treatment study the Lurie Center has participated in since its establishment in 2009.
Read more articles from the 09/21/12 Hotline issue.