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

Primary Purpose

Weight Gain, Autism Spectrum Disorder, Medication Side Effect

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Comparison of Risperidone and Aripiprazole
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain

Eligibility Criteria

undefined - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 17 years and young
  • 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

Sites / Locations

  • Division of Developmental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment with Risperidone

Treatment with Aripiprazole

Arm Description

Patients prescribed Risperidone

Patients prescribed Aripiprazole

Outcomes

Primary Outcome Measures

weight gain
change in weight

Secondary Outcome Measures

Full Information

First Posted
May 21, 2021
Last Updated
April 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04903353
Brief Title
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
Official Title
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Autism Spectrum Disorder, Medication Side Effect

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either Risperidone or Aripiprazole after a clinician has chosen to start the patient on an atypical antipsychotic
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Risperidone
Arm Type
Active Comparator
Arm Description
Patients prescribed Risperidone
Arm Title
Treatment with Aripiprazole
Arm Type
Active Comparator
Arm Description
Patients prescribed Aripiprazole
Intervention Type
Drug
Intervention Name(s)
Comparison of Risperidone and Aripiprazole
Intervention Description
Comparing two FDA approved medications for treatment of irritability in autism
Primary Outcome Measure Information:
Title
weight gain
Description
change in weight
Time Frame
3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Maxwell-Horn, M.D.
Phone
(615) 936-0249
Email
angela.c.maxwell-horn@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Furukawa
Phone
(615) 936-0249
Email
sally.furukawa@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Maxwell-Horn, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Developmental Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Maxwell-Horn
Phone
615-936-0249

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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