Researchers at the UC Davis MIND Institute have received a grant from the U.S. Department of Health and Human Services for a pilot study of whether sertraline, also known by the brand name Zoloft, can be useful in relieving anxiety in very young children diagnosed with fragile X syndrome.
The study will be led by Randi Hagerman, medical director of the UC Davis MIND Institute and one of the world's leading experts on fragile X syndrome, the foremost cause of intellectual disability in the United States and the most common single-gene cause of autism. The grant is for nearly $300,000.
"Our clinical experience and preliminary data shows that the early use of sertraline, which increases serotonin levels at the synapses, helps with the development of language and alleviates anxiety and behavior problems in children with fragile X syndrome," said Hagerman, who is a professor of pediatrics.
Children diagnosed with fragile X syndrome frequently experience severe anxiety, sensory integration deficits, language delays and attention problems. These symptoms usually emerge at around 2 years of age.
Hagerman and her colleagues will recruit 20 children per year for three years for a randomized, case-controlled, clinical trial of the efficacy of sertraline for treating fragile X syndrome.
The study participants, who must be between 2 and 6 years of age, will receive low doses of sertraline for six months, with weekly telephone calls to families to document any side effects and to facilitate dose adjustment, if needed.
After the conclusion of the six-month clinical trial, researchers will use a variety of tests to measure the alleviation of anxiety and behavior problems in study participants. Hagerman said that if the results of the study are promising she anticipates that it will be extended to children with autistic disorder, as well.