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Search / Trial NCT04903353

Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 21, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two medications, risperidone and aripiprazole, which are used to help manage behavior problems in children with autism. The main goal of the study is to find out which medication might cause more weight gain in these children. The trial is being conducted in a real-world setting, meaning that it will take place in a clinical environment where children are regularly seen for their autism treatment.

To participate, children must be 17 years old or younger, have a diagnosis of autism, and be experiencing behavioral issues. They should also be new to these types of medications. Unfortunately, children who are 18 and older or have previously taken similar medications will not be eligible. If your child meets these criteria, they can expect to be part of a study that aims to improve understanding of how these medications affect weight gain. This information could be really helpful for families and doctors when choosing the right treatment for children with autism.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • age 17 years and younger
  • diagnosed with autism
  • have behavior problems
  • seen in Vanderbilt clinic
  • naïve to atypical antipsychotics
  • Exclusion Criteria:
  • 18 years or older
  • history of atypical antipsychotic use
  • not diagnosed with autism

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Angela Maxwell-Horn, M.D.

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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