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

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00337571

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 III

MedlinePlus related topics: Autism

Drug Information available for: Aripiprazole

U.S. FDA Resources

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, Parallel-Group Study With Three Fixed Doses of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in an irritability score [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Clinical Global Impressions (CGI) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Changes in Aberrant Behavior Checklist (ABC) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Other sub-scales and the response rate [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Reduction in compulsive behavior [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Compare tolerability and safety of aripiprazole with placebo [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

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
A1: Experimental 5 mg	Drug: Aripiprazole Tablets, Oral, once daily, 8 weeks
A2: Experimental 10 mg	Drug: Aripiprazole Tablets, Oral, once daily, 8 weeks
A3: Experimental 15 mg	Drug: Aripiprazole Tablets, Oral, once daily, 8 weeks
B1: 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 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

Show 31 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Otsuka America Pharmaceutical

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN138-179
Study First Received:	June 13, 2006
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00337571
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Serious behavioral problems in children and adolescents with AD

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders
Autistic Disorder

Mental Disorders Diagnosed in Childhood
Aripiprazole
Behavioral Symptoms

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009