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NCT01333072 · ClinicalTrials.gov registry record · Phase 4
Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT01333072: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT01333072 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01333072, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments for which evidence-based support is sparse.
Primary Outcome
Multi-center, blinded clinical trial to evaluate biomarkers as predictors of efficacy and safety in children with autistic disorder to risperidone, an atypical antipsychotic drug and aripiprazole, an antipsychotic having a unique clinical and receptor-binding profile. The major outcome measure was the score on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I) . The ABC has 58 items describing some aspect of behavior and the Irritability sub-scale has 15 items, each completed
Interventions
- DRUG Risperidone
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT01333072 record still lists
NCT01333072 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Risperidone is the first listed.
NCT01333072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01333072 about?
NCT01333072 is a clinical study titled "Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)". The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves 3 academic centers across South Carolina. Although the FDA has approved use of the antipsychotic drug ri...
What is the current status of trial NCT01333072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2011-07. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01333072?
The interventions under investigation include: Risperidone (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT01333072?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01333072's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 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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