RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-01
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04903353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * age 17 years and younger
  2. * diagnosed with autism
  3. * have behavior problems
  4. * seen in Vanderbilt clinic
  5. * naïve to atypical antipsychotics
  1. * 18 years or older
  2. * history of atypical antipsychotic use
  3. * not diagnosed with autism

Contacts and Locations

Study Contact

Angela Maxwell-Horn, M.D.
CONTACT
(615) 936-0249
angela.c.maxwell-horn@vumc.org
Sally Furukawa
CONTACT
(615) 936-0249
sally.furukawa@vumc.org

Principal Investigator

Angela Maxwell-Horn, M.D.
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Division of Developmental Medicine
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Angela Maxwell-Horn, M.D., PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Weight Gain
  • Autism Spectrum Disorder
  • Medication Side Effect