Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Behavioral Symptoms, Autistic Disorder
About this trial
This is an interventional treatment trial for Behavioral Symptoms focused on measuring Serious behavioral problems in children and adolescents with AD
Eligibility Criteria
Inclusion Criteria: 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 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, 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
Sites / Locations
- University Of Alabama At Birmingham
- Harmonex Neuroscience
- Southwest Autism Research And Resource Center
- Clinical Innovations, Inc.
- University Of California-Davis Medical Center
- Stanford University School Of Medicine
- The Children'S Hospital
- Marsella, Gregory
- University Of Florida
- University Of South Florida
- Institute For Behavioral Medicine
- University Of Illinois At Chicago
- Cambridge Health Alliance
- Ladders Clinic
- Children'S Hospital Of Michigan
- Regions Hospital
- Children'S Mercy Hospital
- Munroe-Meyer Institute
- North Shore - Long Island Jewish Health System
- Seaver And New York Autism Center Of Excellence
- Richmond Behavioral Associates
- Mission Hospitals
- Duke Child And Family Study Center
- The Nisonger Center
- Cutting Edge Research
- Western Psychiatric Institute And Clinic
- Dallas Pediatric Neurology Associates
- Bayou City Research, Ltd.
- Children'S National Medical Center
- Pacific Institute Of Medical Sciences
- Children'S Hospital Of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
A1
A2
A3
B1
5 mg
10 mg
15 mg