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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
Tablets, Oral, once daily, 8 weeks
Marsella, Gregory
Boca Raton, Florida, United States
Child Neurology Associates, Pc
Atlanta, Georgia, United States
University Of Louisville
Louisville, Kentucky, United States
Neurobehavioral Medicine Group
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
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.
Time frame: Week 8
Mean Clinical Global Impressions Improvement Scale (CGI-I) Score
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).
Time frame: Week 8
Number of Participants With Response at 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
Time frame: Week 8
Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)
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.
Time frame: Week 8
Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores
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
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Bloomfield Hills, Michigan, United States
Center For Psychiatry And Behavioral Medicine
Las Vegas, Nevada, United States
Suny - Stony Brook School Of Medicine
Stony Brook, New York, United States
Univ Of Nc
Chapel Hill, North Carolina, United States
Ut Medical Group
Memphis, Tennessee, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, United States
Time frame: Week 8
Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)
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.
Time frame: Week 8
Summary of Safety
Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
Time frame: continuous throughout the study
Change From Baseline in Body Weight
Adjusted mean change (Week 8 - baseline) in body weight
Time frame: Week 8