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

Completed · Phase 4

Conditions studied: Weight Gain, Autism Spectrum Disorder, Medication Side Effect

In brief

This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders. This trial, done in the context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children.

Key facts

Study ID

NCT04903353

Run by

Vanderbilt University Medical Center

People needed

30

Starts

2022-02-01

Expected to finish

2025-12-01

Last updated by the study team

2026-04-13

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 17 years and younger
• diagnosed with autism
• have behavior problems
• seen in Vanderbilt clinic
• naïve to atypical antipsychotics

You may not qualify if…

• 18 years or older
• history of atypical antipsychotic use
• not diagnosed with autism

Where it is running

• Division of Developmental Medicine — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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