N/A
Completed N=528
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Source: ClinicalTrials.gov NCT03179787 ↗Enrolled (actual)
528
Serious AEs
0.6%
Results posted
Sep 2021
Primary outcomePrimary: Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. — 19.8; 14.7; 12.9; 12.7 score on a scale
Summary
The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline. |
19.8; 14.7; 12.9; 12.7; 13.4; 13.1 | — |
Eligibility Criteria
Inclusion Criteria
- diagnosed as autism with irritability
Exclusion Criteria
- patients who has ever been treated with aripiprazole
Data sourced from ClinicalTrials.gov (NCT03179787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.