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

NCT04903353 | Completed Phase 4 FDA Drug

• 1 other identifier: 210757
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain; Autism Spectrum Disorder; Medication Side Effect

Outcome Measures

Primary Outcomes (1)

• weight gain

  change in weight

  3 months

Study Arms (2)

Treatment with Risperidone

ACTIVE COMPARATOR

Patients prescribed Risperidone

Drug: Comparison of Risperidone and Aripiprazole

Treatment with Aripiprazole

ACTIVE COMPARATOR

Patients prescribed Aripiprazole

Drug: Comparison of Risperidone and Aripiprazole

Interventions

Comparison of Risperidone and Aripiprazole DRUG

Comparing two FDA approved medications for treatment of irritability in autism

Treatment with Aripiprazole; Treatment with Risperidone

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• years or older
• history of atypical antipsychotic use
• not diagnosed with autism

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Division of Developmental Medicine

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Weight Gain; Autism Spectrum Disorder; Drug-Related Side Effects and Adverse Reactions

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Angela Maxwell-Horn, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: Participants will be randomly assigned to either Risperidone or Aripiprazole after a clinician has chosen to start the patient on an atypical antipsychotic

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: February 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)