Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337571
First received: June 13, 2006
Last updated: August 3, 2010
Last verified: November 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Behavioral Symptoms Autistic Disorder |
Drug: Aripiprazole Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Enrollment: | 218 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A1
5 mg
|
Drug: Aripiprazole
Tablets, Oral, once daily, 8 weeks
Other Name: Abilify
|
|
Experimental: A2
10 mg
|
Drug: Aripiprazole
Tablets, Oral, once daily, 8 weeks
Other Name: Abilify
|
|
Experimental: A3
15 mg
|
Drug: Aripiprazole
Tablets, Oral, once daily, 8 weeks
Other Name: Abilify
|
| Placebo Comparator: B1 |
Drug: Placebo
Tablets, Oral, once daily, 8 weeks
|
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337571
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| United States, Alabama | |
| University Of Alabama At Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| Harmonex Neuroscience | |
| Dothan, Alabama, United States, 36303 | |
| United States, Arizona | |
| Southwest Autism Research And Resource Center | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Clinical Innovations, Inc. | |
| Huntington Beach, California, United States, 92647 | |
| University Of California-Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| Stanford University School Of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| The Children'S Hospital | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Marsella, Gregory | |
| Boca Raton, Florida, United States, 33432 | |
| University Of Florida | |
| Gainesville, Florida, United States, 32611 | |
| University Of South Florida | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Institute For Behavioral Medicine | |
| Smyrna, Georgia, United States, 30080 | |
| United States, Illinois | |
| University Of Illinois At Chicago | |
| Chicago, Illinois, United States, 60606 | |
| United States, Massachusetts | |
| Cambridge Health Alliance | |
| Medford, Massachusetts, United States, 02139 | |
| Ladders Clinic | |
| Wellsley, Massachusetts, United States, 02481 | |
| United States, Michigan | |
| Children'S Hospital Of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Regions Hospital | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Missouri | |
| Children'S Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Munroe-Meyer Institute | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New York | |
| North Shore - Long Island Jewish Health System | |
| Bethpage, New York, United States, 11714 | |
| Seaver And New York Autism Center Of Excellence | |
| New York, New York, United States, 10029 | |
| Richmond Behavioral Associates | |
| Staten Island, New York, United States, 10312 | |
| United States, North Carolina | |
| Mission Hospitals | |
| Asheville, North Carolina, United States, 28801 | |
| Duke Child And Family Study Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| The Nisonger Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Cutting Edge Research | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Pennsylvania | |
| Western Psychiatric Institute And Clinic | |
| Pittsburgh, Pennsylvania, United States, 15203 | |
| United States, Texas | |
| Dallas Pediatric Neurology Associates | |
| Dallas, Texas, United States, 75230 | |
| Bayou City Research, Ltd. | |
| Houston, Texas, United States, 77007 | |
| United States, Virginia | |
| Children'S National Medical Center | |
| Fairfax, Virginia, United States, 22031 | |
| United States, Washington | |
| Pacific Institute Of Medical Sciences | |
| Bothell, Washington, United States, 98011 | |
| United States, Wisconsin | |
| Children'S Hospital Of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53201 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Otsuka America Pharmaceutical
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications:
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00337571 History of Changes |
| Other Study ID Numbers: | CN138-179 |
| Study First Received: | June 13, 2006 |
| Results First Received: | June 3, 2009 |
| Last Updated: | August 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Serious behavioral problems in children and adolescents with AD |
Additional relevant MeSH terms:
|
Autistic Disorder Behavioral Symptoms Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Aripiprazole Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013