Status:
RECRUITING
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Weight Gain
Autism Spectrum Disorder
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Autism is a developmental disability with increasing prevalence in our society. Currently one out of fifty-nine children in the United States has this condition. Many children with autism experience b...
Eligibility Criteria
Inclusion
- age 17 years and younger
- diagnosed with autism
- have behavior problems
- seen in Vanderbilt clinic
- naïve to atypical antipsychotics
Exclusion
- 18 years or older
- history of atypical antipsychotic use
- not diagnosed with autism
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04903353
Start Date
February 1 2022
End Date
December 1 2025
Last Update
August 5 2025
Active Locations (1)
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1
Division of Developmental Medicine
Nashville, Tennessee, United States, 37212