Clinical Trial: Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With

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 Summary:
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: Change in an irritability score

Current Secondary Outcome:

  • Mean Clinical Global Impressions Improvement Scale (CGI-I) Score [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
  • Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: continuous throughout the study ]
    Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation
  • Change From Baseline in Body Weight [ Time Frame: Week 8 ]
    Adjusted mean change (Week 8 - baseline) in body weight


Original Secondary Outcome: Changes in clinical global impression, Changes in checklist for aberrant behavior, other sub-scales and the response rate, Reduction in compulsive behavior, Compare tolerability and safety of aripiprazole with placebo

Information By: Otsuka Pharmaceutical Development & Commercialization, Inc.

Dates:
Date Received: May 31, 2006
Date Started: June 2006
Date Completion:
Last Updated: November 7, 2013
Last Verified: December 2009