Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD) - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00332241

Purpose

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	Intervention	Phase
Autistic Disorder	Drug: Aripiprazole Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Autism

Drug Information available for: Aripiprazole

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	98
Study Start Date:	June 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental Active Abilify	Drug: Aripiprazole Tablets, Oral, 5, 10, or 15 mg, once daily, 8 weeks
A2: Placebo Comparator	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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332241

Locations

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

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-178
Study First Received:	May 31, 2006
Results First Received:	June 3, 2009
Last Updated:	June 3, 2009
ClinicalTrials.gov Identifier:	NCT00332241 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Serious behavioral problems in children and adolescents with AD
Behavioral Problems

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Child Development Disorders, Pervasive

Pathologic Processes
Autistic Disorder
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Aripiprazole
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009