Comparing weight gain in children with autism taking two medications
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
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 |
| Enrollment | 350 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT04903353 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are 18 years or older or have a history of atypical antipsychotic use will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.