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

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

MedlinePlus related topics:

Autism

ChemIDplus related topics:

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, Flexible-Dosed, Parallel-Group Study of Aripiprazole Flexibly Dosed 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 impression (CGI) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Changes in checklist for aberrant behavior, 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:	164
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	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:	CN138-178
First Received:	May 31, 2006
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00332241
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

Study placed in the following topic categories:

Child Development Disorders, Pervasive

Developmental Disabilities

Mental Disorders

Autistic Disorder

Mental Disorders Diagnosed in Childhood

Aripiprazole

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 September 04, 2008

Sponsors and Collaborators:	Bristol-Myers Squibb Otsuka America Pharmaceutical
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00332241