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Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study has been completed.
Study NCT00332241   Information provided by Bristol-Myers Squibb
First Received: May 31, 2006   Last Updated: June 3, 2009   History of Changes

May 31, 2006
June 3, 2009
June 2006
April 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 ]
Change in an irritability score
Complete list of historical versions of study NCT00332241 on ClinicalTrials.gov Archive Site
  • Mean Clinical Global Impressions Improvement Scale (CGI-I) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of Participants With Response at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 CGI-Severity (CGI-S) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Summary of Safety [ Time Frame: continuous throughout the study ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Weight [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
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
 
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
A Multicenter Double-Blind, Randomized, Placebo-Controlled, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed in the Treatment of Children and Adolescents With Autistic Disorder (AD)

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).

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Autistic Disorder
  • Drug: Aripiprazole
  • Drug: Placebo
Experimental: Active Abilify
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
98
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

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, 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.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00332241
Study Director, Bristol-Myers Squibb
CN138-178
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2009

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