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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332241
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : July 23, 2009
Last Update Posted : December 2, 2013
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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).

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Aripiprazole Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Autistic Disorder (AD)
Study Start Date : June 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A1
Active Abilify
Drug: Aripiprazole
Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
Other Name: Abilify

Placebo Comparator: A2 Drug: Placebo
Tablets, Oral, once daily, 8 weeks

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. Summary of Safety [ Time Frame: continuous throughout the study ]
    Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation

  7. Change From Baseline in Body Weight [ Time Frame: Week 8 ]
    Adjusted mean change (Week 8 - baseline) in body weight

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332241

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United States, Florida
Marsella, Gregory
Boca Raton, Florida, United States, 33432
United States, Georgia
Child Neurology Associates, Pc
Atlanta, Georgia, United States, 30342
United States, Kentucky
University Of Louisville
Louisville, Kentucky, United States, 40202
United States, Michigan
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
United States, Nevada
Center For Psychiatry And Behavioral Medicine
Las Vegas, Nevada, United States, 89128
United States, New York
Suny - Stony Brook School Of Medicine
Stony Brook, New York, United States, 11794
United States, North Carolina
Univ Of Nc
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Ut Medical Group
Memphis, Tennessee, United States, 38105
United States, Texas
Red Oak Psychiatry Associates, Pa
Houston, Texas, United States, 77090
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00332241    
Other Study ID Numbers: CN138-178
First Posted: June 1, 2006    Key Record Dates
Results First Posted: July 23, 2009
Last Update Posted: December 2, 2013
Last Verified: December 2009
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Serious behavioral problems in children and adolescents with AD
Behavioral Problems
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists