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

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00337571
First received: June 13, 2006
Last updated: November 7, 2013
Last verified: November 2009

June 13, 2006
November 7, 2013
June 2006
June 2008   (final data collection date for primary outcome measure)
Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
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.
Change in an irritability score
Complete list of historical versions of study NCT00337571 on ClinicalTrials.gov Archive Site
  • Mean Clinical Global Impressions Improvement Scale (CGI-I) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: continuously throughout the study ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Adjusted mean change (Week 8 - baseline) in body weight
Changes in clinical global impressions, 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
Not Provided
Not Provided
 
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
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)

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Behavioral Symptoms
  • Autistic Disorder
  • Drug: Aripiprazole
    Tablets, Oral, once daily, 8 weeks
    Other Name: Abilify
  • Drug: Placebo
    Tablets, Oral, once daily, 8 weeks
  • Experimental: A1
    5 mg
    Intervention: Drug: Aripiprazole
  • Experimental: A2
    10 mg
    Intervention: Drug: Aripiprazole
  • Experimental: A3
    15 mg
    Intervention: Drug: Aripiprazole
  • Placebo Comparator: B1
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00337571
CN138-179
Yes
Study Director, Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP