Weight GainPhase 4NCT04903353
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
A Phase 4 study testing Comparison of Risperidone and Aripiprazole in people with Weight Gain and Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Autism Spectrum Disorder, Medication Side Effect
- What is being tested?
- Comparison of Risperidone and Aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Dec 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 17 years and younger
- diagnosed with autism
- have behavior problems
- seen in Vanderbilt clinic
- naïve to atypical antipsychotics
Who cannot join
- 18 years or older
- history of atypical antipsychotic use
- not diagnosed with autism
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Developmental Medicine
Nashville, Tennessee, 37212
About this study
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.
Read the 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.
- Being tested
- Comparison of Risperidone and Aripiprazole
- Medical subject headings
- Weight Gain, Autism Spectrum Disorder, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of Risperidone and AripiprazoleDrug
Comparing two FDA approved medications for treatment of irritability in autism
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Risperidone | Active comparator | Patients prescribed Risperidone Receives: Drug: Comparison of Risperidone and Aripiprazole |
| Treatment with Aripiprazole | Active comparator | Patients prescribed Aripiprazole Receives: Drug: Comparison of Risperidone and Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
change in weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Feb 2022
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Maxwell-Horn, Vanderbilt University Medical Center
- Investigators
- Angela Maxwell-Horn, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903353
- Sponsor's protocol ID
- 210757
- Status last verified
- Sep 2026
- First submitted
- 21 May 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No