An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders
Autism, Asperger's Disorder, Pervasive Developmental Disorder
About this trial
This is an interventional treatment trial for Autism focused on measuring behavioral problems, aggression, autism, aripiprazole
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.
Sites / Locations
- Cambridge Health Alliance
Arms of the Study
Arm 1
Experimental
Aripiprazole
aripiprazole monotherapy, begun at 2.5 mg or 5.0 mg based on clinical impression and severity of aggression and agitation. Dose to be adjusted in not more than 5 mg increments, weekly. The lowest effective dose will be used up to a maximum daily dose of 20 mg.