NCT00337571CompletedPhase 3
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
Otsuka Pharmaceutical Development & Commercialization, Inc.61 sites in 1 country218 target enrollmentStarted: June 1, 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 218
- Locations
- 61
- Primary Endpoint
- Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
B1
Placebo Comparator
Intervention: Placebo (Drug)
A1
Experimental
5 mg
Intervention: Aripiprazole (Drug)
A2
Experimental
10 mg
Intervention: Aripiprazole (Drug)
A3
Experimental
15 mg
Intervention: Aripiprazole (Drug)
Outcomes
Primary Outcomes
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score
Time Frame: 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 Outcomes
- Mean Clinical Global Impressions Improvement Scale (CGI-I) Score(Week 8)
- Number of Participants With Response at Week 8(Week 8)
- Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)(Week 8)
- Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores(Week 8)
- Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)(Week 8)
- Summary of Safety(continuously throughout the study)
- Change From Baseline in Body Weight(Week 8)
Investigators
Study Sites (61)
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