Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
With
Otsuka America Pharmaceutical
Age
6–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for AD and demonstrates serious behavioral problems; diagnosis confirmed by Autism, Diagnostic Interview-Revised (ADI-R).
CGI score \> = 4 AND an 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
You may not be if
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, schizophrenia, or major depression
A seizure in the past year
History of severe head trauma or stroke
Non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
Clareo Health | Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
