Phase 3
Completed N=86
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Autistic Disorder
Source: ClinicalTrials.gov NCT01617460 ↗
Enrolled (actual)
86
Serious AEs
11.6%
Results posted
Oct 2017
Primary outcomePrimary: Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score — -3.2 units on a scale
◆ Published Evidence
Established
32citations · ~4 / year
An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan.
Summary
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
Linked Publications
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An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score |
-3.2 | — |
Eligibility Criteria
Inclusion Criteria
- The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
- The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
- Inpatient or outpatient status
Exclusion Criteria
- The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
- Patients who fall under a contraindication listed in the ABILIFY package insert
- Others
Data sourced from ClinicalTrials.gov (NCT01617460) and the linked publication. 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.