Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
- Conditions
- Behavioral SymptomsAutistic Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT00337571
- Brief Summary
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 Aripiprazole 5 mg A2 Aripiprazole 10 mg A3 Aripiprazole 15 mg B1 Placebo -
- Primary Outcome Measures
Name Time Method Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score Week 8 The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement.
- Secondary Outcome Measures
Name Time Method Mean Clinical Global Impressions Improvement Scale (CGI-I) Score Week 8 The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse).
Number of Participants With Response at Week 8 Week 8 Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint.
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) Week 8 CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients \<18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement.
Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores Week 8 Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement.
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) Week 8 A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement.
Summary of Safety continuously throughout the study Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
Change From Baseline in Body Weight Week 8 Adjusted mean change (Week 8 - baseline) in body weight
Trial Locations
- Locations (31)
Cambridge Health Alliance
🇺🇸Medford, Massachusetts, United States
Clinical Innovations, Inc.
🇺🇸Huntington Beach, California, United States
University Of Florida
🇺🇸Gainesville, Florida, United States
Stanford University School Of Medicine
🇺🇸Stanford, California, United States
Institute For Behavioral Medicine
🇺🇸Smyrna, Georgia, United States
Ladders Clinic
🇺🇸Wellsley, Massachusetts, United States
Regions Hospital
🇺🇸St. Paul, Minnesota, United States
North Shore - Long Island Jewish Health System
🇺🇸Bethpage, New York, United States
Seaver And New York Autism Center Of Excellence
🇺🇸New York, New York, United States
Pacific Institute Of Medical Sciences
🇺🇸Bothell, Washington, United States
University Of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
University Of South Florida
🇺🇸Tampa, Florida, United States
Children'S Hospital Of Michigan
🇺🇸Detroit, Michigan, United States
The Nisonger Center
🇺🇸Columbus, Ohio, United States
Harmonex Neuroscience
🇺🇸Dothan, Alabama, United States
Southwest Autism Research And Resource Center
🇺🇸Phoenix, Arizona, United States
University Of California-Davis Medical Center
🇺🇸Sacramento, California, United States
University Of Illinois At Chicago
🇺🇸Chicago, Illinois, United States
Children'S Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Munroe-Meyer Institute
🇺🇸Omaha, Nebraska, United States
The Children'S Hospital
🇺🇸Aurora, Colorado, United States
Marsella, Gregory
🇺🇸Boca Raton, Florida, United States
Duke Child And Family Study Center
🇺🇸Durham, North Carolina, United States
Dallas Pediatric Neurology Associates
🇺🇸Dallas, Texas, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Mission Hospitals
🇺🇸Asheville, North Carolina, United States
Cutting Edge Research
🇺🇸Oklahoma City, Oklahoma, United States
Western Psychiatric Institute And Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
Bayou City Research, Ltd.
🇺🇸Houston, Texas, United States
Children'S National Medical Center
🇺🇸Fairfax, Virginia, United States
Children'S Hospital Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States