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Atypical Antipsychotic

Risperidone vs Aripiprazole for Weight Gain in Children with Autism

Phase 4

Recruiting

Led By Angela Maxwell-Horn, M.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 17 years and younger

Naïve to atypical antipsychotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will compare the weight gain of children taking aripiprazole or risperidone for behavioral dysregulation in autism spectrum disorders.

Who is the study for?

This trial is for children up to 17 years old with autism spectrum disorder who have behavioral issues and haven't used atypical antipsychotics before. They must be patients at the Vanderbilt clinic.Check my eligibility

What is being tested?

The study compares weight gain in children with autism when treated with two FDA approved medications: Risperidone and Aripiprazole, during routine clinical care.See study design

What are the potential side effects?

Possible side effects of both Risperidone and Aripiprazole include significant weight gain, drowsiness, increased appetite, fatigue, insomnia, and potential metabolic changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 17 years old or younger.

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I have never taken atypical antipsychotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

weight gain

Trial Design

2Treatment groups

Active Control

Group I: Treatment with RisperidoneActive Control1 Intervention

Patients prescribed Risperidone

Group II: Treatment with AripiprazoleActive Control1 Intervention

Patients prescribed Aripiprazole

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

671,847 Total Patients Enrolled

36 Trials studying Obesity

6,881 Patients Enrolled for Obesity

Angela Maxwell-Horn, M.D.Principal InvestigatorVanderbilt University Medical Center

Media Library

Aripiprazole (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT04903353 — Phase 4

Obesity Research Study Groups: Treatment with Risperidone, Treatment with Aripiprazole

Obesity Clinical Trial 2023: Aripiprazole Highlights & Side Effects. Trial Name: NCT04903353 — Phase 4

Aripiprazole (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903353 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what afflictions is treatment with risperidone usually deployed?

"Risperidone is a medication often prescribed to reduce irritability as well as agitation, Alzheimer's disease and Behcet Syndrome."

Answered by AI

Are there still openings for volunteers to participate in this research?

"Correct. Data hosted on clinicaltrials.gov reveals that this medical experiment, which was initially posted on February 1st 2022, is actively searching for participants. The study has recently been updated as of March 10th 2022."

Answered by AI

Has there been any prior research concerning the utilization of Risperidone?

"Presently, 24 clinical trials are in progress to evaluate the efficacy of risperidone. 6 of those experiments have reached phase 3 status. Most studies for this medication take place in Toronto, Ontario but there are 149 sites participating worldwide."

Answered by AI

How many individuals are participating in this experiment?

"Affirmative. Clinicaltrials.gov has information which confirms that this research is currently seeking participants, with the initial post made on February 1st 2022 and most recent update happening March 10th 2022. This trial needs to find 350 individuals from one site in particular."

Answered by AI