Phase 2
N=30
Study of Aripiprazole to Treat Children and Adolescents With Autism
Autistic Disorder · Asperger Syndrome · Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00619190 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks — 7.6; -0.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- aripiprazole (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks |
7.6; -0.6 | — |
| SECONDARY Clinical Global Impressions Scale - Severity Score (CGI-S) |
5.35; 4.5 | — |
| SECONDARY Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks |
-4.5; -0.3 | — |
Summary
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.
Eligibility Criteria
Inclusion Criteria
- Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
- Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
- Have a guardian who is able and willing to give written informed consent
- If competent, subject able and willing to give written assent for their own participation
- If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
- Subjects may receive other nonpharmacologic treatment including dietary treatments
Exclusion Criteria
- Diagnosis of Rett's syndrome or Child Disintegrative Disorder
- Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
- Previous trial of aripiprazole
- Pregnant or nursing
- Epilepsy or another significant chronic medical illness
Data sourced from ClinicalTrials.gov (NCT00619190). 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.