Comparing weight gain in children with autism taking two medications
Official title: Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
Run by Vanderbilt University Medical Center · NCT04903353 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing which of two medications for children with autism causes less weight gain to help doctors make better treatment choices.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 17 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04903353 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children under 18 years old diagnosed with autism who exhibit behavioral dysregulation and have not previously been treated with atypical antipsychotics.
✕Probably not a fit
Patients who are 18 years or older or have a history of atypical antipsychotic use will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effects of two FDA-approved medications, aripiprazole and risperidone, on weight gain in children with autism spectrum disorder who exhibit behavioral dysregulation. Conducted in a real-world clinical setting, the trial aims to determine which medication is associated with less weight gain. Participants must be under 18 years old, diagnosed with autism, and naïve to atypical antipsychotic treatment. The study will help inform treatment choices and address the cardiometabolic risks associated with these medications.
Why it matters
Potential benefit: If successful, this study could help guide medication choices for children with autism, potentially reducing the risk of weight gain and associated health issues.
How similar studies have gone: Previous studies have suggested differences in weight gain between these medications, but this trial aims to provide clearer clinical insights in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Division of Developmental Medicine
Nashville, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Angela Maxwell-Horn, M.D. — Vanderbilt University Medical Center
- Study coordinator: Angela Maxwell-Horn, M.D.
- Email: angela.c.maxwell-horn@vumc.org
- Phone: (615) 936-0249
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.