Lead by MIND Institute Medical Director Randi Hagerman, the study will examine whether treating 2- to 5-year-old children with sertraline can stimulate both their language and socialization and improve their behavior.
“There is a great need to develop treatments for children with autism early on because this is the time to rectify the abnormalities in the brain that are taking place with autism, within this very early developmental window,” said Hagerman, Distinguished Professor and Fragile X Endowed Chair in the Department of Pediatrics.
“We believe that the use of a low-dose SSRI in early childhood, in addition to enrollment in community behavioral and therapy programs, will have a significant effect on behavior, language and development in young children with autism,” she said. Sertraline is approved by the Food and Drug Administration for children 6 years and older for treatment of anxiety and obsessive-compulsive disorder, but not for autism.
The current study will enroll 20 children, male and female, 2 to 5 years old inclusive each year for a total of three years. Each child will come in for three visits over a six month period. The study will compare sertraline to a placebo and each child has a 50 percent chance of receiving either. The children must be receiving school- or home-based behavioral intervention for their autism. For information regarding participation in the study, please contact Lindsay Derby at firstname.lastname@example.org, 916-703-0472.