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

Phase 4

Recruiting

• Conditions: Weight Gain; Autism Spectrum Disorder; Medication Side Effect
• Interventions: Drug: Comparison of Risperidone and Aripiprazole

• Registration Number: NCT04903353
• Lead Sponsor: Vanderbilt University Medical Center

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 context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children.

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 behavioral dysregulation such as irritability and aggression.

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.

Study Timeline

• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-26
• Study Start: 2022-02-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Aripiprazole	Comparison of Risperidone and Aripiprazole	Patients prescribed Aripiprazole
Treatment with Risperidone	Comparison of Risperidone and Aripiprazole	Patients prescribed Risperidone

Primary Outcome Measures

Name	Time	Method
weight gain	3 months	change in weight

Trial Locations

Locations (1)

Division of Developmental Medicine; 🇺🇸 Nashville, Tennessee, United States