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NCT04903353 · ClinicalTrials.gov registry record · Phase 4
Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT04903353: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT04903353 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04903353, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
change in weight
Interventions
- DRUG Comparison of Risperidone and Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 4 |
What the finished NCT04903353 record still lists
NCT04903353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Comparison of Risperidone and Aripiprazole is the first listed.
NCT04903353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04903353 about?
NCT04903353 is a clinical study titled "Pragmatic Trial Comparing Weight Gain in Children With Autism Taking Risperidone Versus Aripiprazole". 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 asso...
What is the current status of trial NCT04903353?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2022-02-01. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT04903353?
The interventions under investigation include: Comparison of Risperidone and Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT04903353?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04903353's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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