Phase 2 N=14 Treatment

An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

Autism · Asperger's Disorder · Pervasive Developmental Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00308074 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Clinical Global Impressions-Improvement — 1.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aripiprazole (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Cambridge Health Alliance
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Global Impressions-Improvement	1.8	—
PRIMARY Aberrant Behavior Checklist-Irritability Subscale	24.5; 8	—
SECONDARY Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	15.9; 9.9	—
SECONDARY Brief Psychiatric Rating Scale for Children (BPRS-C)	69.0; 36.1	—

Summary

The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.

Eligibility Criteria

Inclusion Criteria

Males and Females ages 6-17
A diagnosis of Autism, Asperger's Disorder, or Pervasive Developmental Disorder - not otherwise specified (PDD NOS)
Medically healthy
Ability to give assent
Significant tantrums, aggression, self-injurious behavior and/or agitation by achieving a score of 18 or higher on the Aberrant Behavior Checklist-irritability subscale and a score of moderate or higher on the Clinical Global Impressions-Severity Scale.

Exclusion Criteria

Co-morbid serious mental illness.
Intelligence Quotient (IQ) <50, based on verified records of cognitive testing performed within 2 years of enrollment. In event that suitable records of prior testing are unavailable, IQ will be estimated using the Wechsler Abbreviated Scale of Intelligence (WASI, 1999 Harcourt Assessment, Inc.).
Significant active medical and/or neurological illness.
Subjects that require other psychotropic medications such as antidepressants, mood stabilizers, anticonvulsants, stimulants, sedatives, or other antipsychotic medications in order to maintain clinical stability.
Active substance abuse/dependence based upon history and urine toxicology screen.
Inability to have blood drawn at baseline and termination visits.
Known allergy or hypersensitivity to aripiprazole or its ingredients.
Patients clinically stable on current medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00308074). 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.