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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Weight Gain; Medication Side Effect
• Intervention / Treatment: Drug: Comparison of Risperidone and Aripiprazole

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 Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Angela Maxwell-Horn, M.D.; Phone Number: (615) 936-0249; Email: angela.c.maxwell-horn@vumc.org
• Study Contact Backup: Name: Sally Furukawa; Phone Number: (615) 936-0249; Email: sally.furukawa@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Recruiting
      • Division of Developmental Medicine
      • Contact: Angela Maxwell-Horn; Phone Number: 615-936-0249

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment with Risperidone; Patients prescribed Risperidone	Drug: Comparison of Risperidone and Aripiprazole; Comparing two FDA approved medications for treatment of irritability in autism
Active Comparator: Treatment with Aripiprazole; Patients prescribed Aripiprazole	Drug: Comparison of Risperidone and Aripiprazole; Comparing two FDA approved medications for treatment of irritability in autism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight gain	change in weight	3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Angela Maxwell-Horn, M.D., Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimated): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Body Weight Changes; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Body Weight; Autistic Disorder; Autism Spectrum Disorder; Weight Gain; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole; Risperidone
• Other Study ID Numbers: 210757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No