LAPS

Long-term Antipsychotic Pediatric Safety Trial (LAPS)

Summary

The primary objective of this 2-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 and ~350 children treated with aripiprazole at the time of enrollment. 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.

Publications

    OVERVIEW

    Status:
    Enrolling

    ClinicalTrials.gov identifier:
    NCT03522168

    Principal Investigator:
    Linmarie Sikich, MD, MPH
    Duke Department of Psychiatry and Behavioral Sciences; Duke Center for Autism and Brain Development

    NEWS

    • LAPS Trial Meets Study and Sub-Study Milestones
      The PTN Long-term Antipsychotic Pediatric Safety (LAPS) Trial, which aims to assess the long-term health of risperidone and aripiprazole in children, has enrolled more than 500 children in the main study. Risperidone and aripiprazole have been shown to be effective for the treatment of conditions such as schizophrenia and bipolar disorder in adults and children. ...
    • LAPS trial achieves substantial enrollment milestone
      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 ...
    • PTN LAPS Trial enrolls more than 100 patients
      The PTN Long-term Antipsychotic Pediatric Safety (LAPS) Trial, which aims to assess the long-term health risks of risperidone and aripiprazole in children, has now enrolled more than 100 children. Risperidone and aripiprazole have been shown to be effective for the treatment of conditions such as schizophrenia and bipolar disorder in adults, but little is known ...
    • First site activated for LAPS study on antipsychotic use in children
      The first site has been activated for the Long-term Antipsychotic Pediatric Safety (LAPS) Trial, which aims to determine the safety of long-term antipsychotic treatments in children. Dr. Ahmed Elmaadawi’s was the first site activated on Tuesday, Dec. 11. Dr. Elmaadawi is the director of the Interventional Psychiatry Program at Beacon Health System in South Bend, ...