Phase 3
N=92
A Short Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01617447 ↗Enrolled (actual)
92
Serious AEs
1.1%
Results posted
Apr 2017
Primary outcome: Primary: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score — -11.4; -7.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo of Aripiprazole (Drug); Aripiprazole (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score |
-11.4; -7.5 | — |
Summary
The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder
Eligibility Criteria
Inclusion Criteria
- The patient meets current DSM-IV-TR diagnostic criteria for Autistic Disorder (defined in DSM-IV-TR) and also demonstrates behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these problems.
- Inpatient or outpatient status
- Others
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 (NCT01617447). 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.