Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
Autistic Disorder, Behavioral Symptoms
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring Serious behavioral problems in children and adolescents with AD, behavioral problems
Eligibility Criteria
Inclusion Criteria - Rollover: Completed 8 weeks of treatment in one of the following double-blind clinical trials: CN138-178 [NCT00332241] or CN138-179 [NCT00337571] No significant protocol violations and sufficient medical justification to continue on open-label treatment with aripiprazole Inclusion Criteria - De Novo: 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) or the patient meets the current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) diagnostic criteria for AD and has a history of behavioral problems that are currently being treated with psychotropic medication Mental age of at least 18 months Male or female 6 to 17 years of age, inclusive, at the time of enrollment 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 pervasive developmental disorder-not otherwise specified (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
- Univ of Arizona
- Clinical Innovations, Inc
- Peninsula Research Assoc
- University Of California-Davis Health Science Center
- Sharp Mesa Vista Hospital
- Stanford University School Of Medicine
- The Children's Hospital
- Offices of Gregory Marsella, MD, PA
- Sarkis Clinical Trials
- University of Florida
- Miami Children's Hospital
- University of South Florida
- Children's Developmental Center
- Child Neurology Associates, PC
- Institute For Behavioral Medicine
- University of Illinois at Chicago
- Kansas University Medical Center
- University of Louisville
- Massachusetts General Hospital
- Cambridge Health Alliance
- Ladders Clinic
- Neurobehavioral Medicine Group
- Children's Hospital Of Michigan
- Regions Hospital
- Children's Mercy Hospital and Clinics
- Munroe-Meyer Institute Diagnostic Center
- Center for Psychiatry and Behavioral Medicine
- Children's Specialized Hospital
- North Shore - Long Island Jewish Health System
- Seaver and New York Autism Center of Excellence
- Richmond Behavioral Associates
- SUNY at Stony Brook - School of Medicine
- Mission Hospitals - Mission Children's Clinics
- University of NC
- Duke Child and Family Study Center
- University of Cincinnati
- University Hospitals of Cleveland
- The Nisonger Center
- Cutting Edge Research
- Western Psychiatric Institute and Clinic
- UT Medical Group, Department Of Psychiatry
- Dallas Pediatric Neurology Associates
- Bayou City Research, Ltd.
- Red Oak Psychiatry Associates, PA
- North San Antonio Healthcare Associates
- Children's National Medical Center
- Neuroscience, Inc
- Monarch Research Associates
- Virginia Treatment Center For Children
- Pacific Institute of Medical Sciences
- Autism Spectrum Treatment and Research Center
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
De Novo
Rollover Placebo
Rollover Aripiprazole
De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.