Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
NCT ID: NCT04903353
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
350 participants
INTERVENTIONAL
2022-02-01
2025-12-01
Brief Summary
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Detailed Description
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Currently, there are two FDA approved atypical antipsychotic medications that treat irritability in children with autism. These are aripiprazole and risperidone. While it is thought that aripiprazole may cause less weight gain than risperidone, clinically this has not been proven.
Understanding the relative risk of ATAP-induced weight gain that results from risperidone versus aripiprazole in a real-world setting could help guide the choice of medical intervention and reduce the cardiometabolic risks, and, most critically, address the limitations of current studies, which have not been able to provide clear clinical insights given the difficulty with having a representative and robust number of patients enrolled.
To be enrolled in this study, participants must be younger than 18 years of age, on the autism spectrum, have behavioral dysregulation, be naive to treatment with atypical antipsychotics and be seen either in the Division of Developmental Medicine or Child and Adolescent Psychiatry at Vanderbilt University Medical Center.
For enrolled patients, the ordering provider will see an order set, randomized to either aripiprazole or risperidone. They will then choose the recommended antipsychotic that the patient has been randomized to, or override the prompt. If the provider overrides the prompt, they will be asked to provide a reason for not choosing the recommended option.
The outcome measure for this study will be weight gain at a 3 month follow-up visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Treatment with Risperidone
Patients prescribed Risperidone
Comparison of Risperidone and Aripiprazole
Comparing two FDA approved medications for treatment of irritability in autism
Treatment with Aripiprazole
Patients prescribed Aripiprazole
Comparison of Risperidone and Aripiprazole
Comparing two FDA approved medications for treatment of irritability in autism
Interventions
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Comparison of Risperidone and Aripiprazole
Comparing two FDA approved medications for treatment of irritability in autism
Eligibility Criteria
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Inclusion Criteria
* diagnosed with autism
* have behavior problems
* seen in Vanderbilt clinic
* naïve to atypical antipsychotics
Exclusion Criteria
* history of atypical antipsychotic use
* not diagnosed with autism
17 Years
ALL
Yes
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Angela Maxwell-Horn
Assistant Professor of Pediatrics
Principal Investigators
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Angela Maxwell-Horn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Division of Developmental Medicine
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Angela Maxwell-Horn
Role: primary
Other Identifiers
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210757
Identifier Type: -
Identifier Source: org_study_id
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