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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
- ClinicalTrials.gov ID
- NCT04903353
- Acronym / sponsor ID
- 210757
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Treatment with Risperidone | Active comparator | Drug: Comparison of Risperidone and AripiprazolePatients prescribed Risperidone |
| Treatment with Aripiprazole | Active comparator | Drug: Comparison of Risperidone and AripiprazolePatients prescribed Aripiprazole |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 17 years and younger
- diagnosed with autism
- have behavior problems
- seen in Vanderbilt clinic
- naïve to atypical antipsychotics
Key exclusion criteria (3 listed)
- 18 years or older
- history of atypical antipsychotic use
- not diagnosed with autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of Risperidone and AripiprazoleComparing two FDA approved medications for treatment of irritability in autism | Drug | Treatment with Aripiprazole, Treatment with Risperidone |
Primary outcome
weight gain
Time frame: 3 months
change in weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Maxwell-Horn, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight gain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.