Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).

A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)

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).

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.