Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: t
View:
• age 17 years and younger
• diagnosed with autism
• have behavior problems
• seen in Vanderbilt clinic
• naïve to atypical antipsychotics
Locations
United States
Tennessee
Division of Developmental Medicine
RECRUITING
Nashville
Contact Information
Primary
Angela Maxwell-Horn, M.D.
angela.c.maxwell-horn@vumc.org
(615) 936-0249
Backup
Sally Furukawa
sally.furukawa@vumc.org
(615) 936-0249
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 350
Treatments
Active_comparator: Treatment with Risperidone
Patients prescribed Risperidone
Active_comparator: Treatment with Aripiprazole
Patients prescribed Aripiprazole
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center