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NCT04903353CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
30 (actual)
First submitted
21 May 2021
Start date
1 Feb 2022
Primary completion date
1 Dec 2025
Lead sponsor
Vanderbilt University Medical Center
Diseases
Autism
NCT number
NCT04903353

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 30
  • From 1 Feb 2022 to the primary completion date, 1 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • history of atypical antipsychotic use

Other

  • 18 years or older
  • not diagnosed with autism

Who the study is looking for

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

Age in the registry: - to 17 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Division of Developmental Medicine
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.