Phase 3
N=218
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Behavioral Symptoms · Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00337571 ↗Enrolled (actual)
218
Serious AEs
0.9%
Results posted
Jul 2009
Primary outcome: Primary: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score — -8.4; -12.4; -13.2; -14.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aripiprazole (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score |
-8.4; -12.4; -13.2; -14.4 | — |
| SECONDARY Mean Clinical Global Impressions Improvement Scale (CGI-I) Score |
3.3; 2.6; 2.5; 2.5 | — |
| SECONDARY Number of Participants With Response at Week 8 |
17; 29; 29; 28 | — |
| SECONDARY Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) |
-1.7; -2.6; -2.4; -3.2 | — |
| SECONDARY Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores |
-7.7; -14.0; -13.3; -16.3; -1.8; -4.5 | — |
| SECONDARY Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) |
-0.6; -0.9; -1.0; -1.1 | — |
| SECONDARY Summary of Safety |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Body Weight |
0.3; 1.3; 1.3; 1.5 | — |
Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Eligibility Criteria
Inclusion Criteria
- Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for AD and demonstrates serious behavioral problems; diagnosis confirmed by Autism, Diagnostic Interview-Revised (ADI-R).
- CGI score > = 4 AND an ABC Irritability/Agitation subscale score > = 18 at screening and baseline (randomization)
- Mental age of at least 18 months
- Male or female 6 to 17 years of age inclusive, at the time of randomization
Exclusion Criteria
- Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
- Patients previously treated and not responding to aripiprazole treatment
- The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
- Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
Data sourced from ClinicalTrials.gov (NCT00337571). 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.