Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
- Registration Number
- NCT00332241
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A2 Placebo - A1 Aripiprazole Active Abilify
- 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).
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.
Change From Baseline in Body Weight Week 8 Adjusted mean change (Week 8 - baseline) in body weight
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
Summary of Safety continuous throughout the study Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
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 decrease in value indicates improvement.
Trial Locations
- Locations (9)
Univ Of Nc
🇺🇸Chapel Hill, North Carolina, United States
Neurobehavioral Medicine Group
🇺🇸Bloomfield Hills, Michigan, United States
Marsella, Gregory
🇺🇸Boca Raton, Florida, United States
Center For Psychiatry And Behavioral Medicine
🇺🇸Las Vegas, Nevada, United States
Red Oak Psychiatry Associates, Pa
🇺🇸Houston, Texas, United States
Child Neurology Associates, Pc
🇺🇸Atlanta, Georgia, United States
Suny - Stony Brook School Of Medicine
🇺🇸Stony Brook, New York, United States
Ut Medical Group
🇺🇸Memphis, Tennessee, United States
University Of Louisville
🇺🇸Louisville, Kentucky, United States