The PTN Long-term Antipsychotic Pediatric Safety (LAPS) Trial has now passed the halfway mark of enrollment, marking a substantial study milestone.

The two-year LAPS study will follow children aged 3 to 17 who are already taking an antipsychotic (risperidone or aripiprazole) to treat disorders such as schizophrenia, bipolar disorder, and irritability associated with autism. The study will assess both the long-term health risks and quality-of-life benefits of these two drugs, which have been shown to be effective and may even prevent mental illness in adulthood.

“Antipsychotic treatment of children and adolescents has greatly increased over the past 20 years,” said Dr. Linmarie Sikich, principal investigator for the study and associate professor in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine. “At the same time, new evidence suggests an association between antipsychotic use and weight gain. In addition, the incidence of long-term adverse effects such as involuntary movements and hormonal changes is unknown.”

The goal of LAPS is to assess the long-term health risks of risperidone and aripiprazole in children. While several antipsychotics are FDA-approved in children, it is common for these drugs to be prescribed without FDA approval for conditions such as attention-deficit disorder, obsessive-compulsive disorder, and major depression.

The enrollment of more than 350 children helps achieve 50 percent of the overall enrollment goal and is a key accomplishment for the two-year observational study.