The primary objective of this 3-year, prospective observational study is to evaluate the long-term weight gain associated with either of two mono-antipsychotic therapies, risperidone or aripiprazole, in children aged 3-17 years. The study cohort will include ~350 children treated with risperidone at the time of enrollment, ~350 children treated with aripiprazole at the time of enrollment, and a control group of 150 children who are siblings and live in the same home as the treated children. The treated participants’ personal physicians will prescribe their medications over the course of the study. Study data will also provide information about the potential metabolic and neuromotor long-term health effects of pediatric exposure to risperidone and aripiprazole. Since some participants may stop treatment with risperidone or aripiprazole or switch to a different antipsychotic, the study may provide information about the persistence of adverse effects after risperidone or aripiprazole discontinuation or with other second generation antipsychotics.
Linmarie Sikich, MD, MPH
Duke Department of Psychiatry and Behavioral Sciences; Duke Center for Autism and Brain Development