Phase 3
N=98
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00332241 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score — -5.0; -12.9 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
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score |
-5.0; -12.9 | — |
| SECONDARY Mean Clinical Global Impressions Improvement Scale (CGI-I) Score |
3.6; 2.2 | — |
| SECONDARY Number of Participants With Response at Week 8 |
7; 24 | — |
| SECONDARY Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) |
-0.8; -3.8 | — |
| SECONDARY Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores |
-2.8; -12.7; -2.0; -4.8; -0.4; -2.5 | — |
| SECONDARY Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) |
-0.4; -1.2 | — |
| SECONDARY Summary of Safety |
0; 0; 0; 0; 3; 5 | — |
| SECONDARY Change From Baseline in Body Weight |
0.8; 2.0 | — |
Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, 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 for Mental Disorders-Fourth Edition (DSM-IV) diagnostic criteria for AD and demonstrates serious behavioral problems. Diagnosis confirmed by Autism Diagnostic Interview- Revised (ADI-R)
- CGI score > = 4 AND and Aberrant Behavior Checklist (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, or schizophrenia, or major depression
- A seizure in the past year
- History of severe head trauma or stroke
- Patients undergoing non-pharmacologic therapies (e.g., psychotherapy, behavioral modification) must have started at least 2 months prior to the initial screening visit and must remain in a consistent treatment program for the duration of the study.
Data sourced from ClinicalTrials.gov (NCT00332241). 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.