Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children - Full Text View

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00468130

Purpose

Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability checklist.

(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.

The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.

Condition	Intervention	Phase
Autism	Drug: Aripiprazole	Phase III

MedlinePlus related topics: Autism

Drug Information available for: Aripiprazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Clinical Global Impression Improvement (CGI-AD), administered weekly
Aberrant Behavior Checklist, administered weekly
Abnormal Involuntary Movement Scale (AIMS), administered every 4 weeks

Estimated Enrollment:	30
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2007

Detailed Description:

Aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. Multiple clinical trials in both children and adults have shown the effectiveness in the treatment of autism with medications like Aripiprazole. This study aims at assessing the effect of aripiprazole vs. placebo treatment on symptoms of irritability and aggression associated with autism, as well as the effect on the global severity of child and adolescent autistic disorder. Children or adolescent outpatients, with age ranges from 5-17, will be enrolled into an 8-week placebo controlled, double blind treatment study. During the 8 weeks, patients will be monitored by the treating psychiatrist. Study assessments will be administered at designated time points.

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV, ADI-R criteria for autistic disorder.
Age 5-17 years.
Outpatients
Parent or legal guardian willing to sign informed consent.

Exclusion Criteria:

Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
Subject has caused visible harm to him/herself.
Subject has an active seizure disorder or epilepsy (seizures within the past year).
Subject has an unstable medical illness, including heart disease.
Subject has experienced brain injury.
Subject has a history of diabetes.
Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468130

Contacts

Contact: Annie Kutlik, BA, BS

(732)-235-5690

kutlikam@umdnj.edu

Locations

United States, New Jersey
Department of Child and Adolescent Psychiatry, University Behavioral Health Care Building	Recruiting
Piscataway, New Jersey, United States, 08854
Sub-Investigator: Elizabeth Roberts, PsyD
Sub-Investigator: Annie Kutlik, BA, BS
Sub-Investigator: Theodore Petti, MD, MPH

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Investigators

Principal Investigator:

Sherie L. Novotny, MD

Child and Adolescent Psychiatry, UMDNJ

More Information

Official site of the Division of Child and Adolescent Psychiatry This link exits the ClinicalTrials.gov site

Publications:

Aman M, Smgh N, Stewart A, Field C. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects.Am J Ment Defic, 1985a;89(5):485 491 Campbell M, et al, Neuroleptic related dyskinesias in autistic children: a prospective longitudinal study, J Am Acad Child Adolesc Psychiatry 1997; 36(6): 835 43. Fomboime E. The epidemiology of autism: a review. Psychological Medicine, 1999; 29:769 786. Guy W. ECDEU assessment manual for psychopharmacology. Revised. NTMH Publication DHEW Publ No (adm.) 76 388. Bethesda, MD: National Institute of Mental Health, 1976; 217 222. McDougle CJ, Holmes JP, Bronson MR, Anderson GM, Volkmar FR, Price LH, Cohen DJ. Risperidone treatment of children and adolescents with pervasive developmental disorders: a prospective open label study. J Am Acad Child Adolesc Psychiatry. 1997 May;36(5):685 93. Stahl SM. Dopamine system stabilizers, aripiprazole, and the next generation of antipsychotics, J Clin Psychiatry. 2001;62(l1).

Study ID Numbers:	5441
Study First Received:	April 30, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00468130
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

Aggression
Irritability
Global autism severity

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders
Autistic Disorder

Mental Disorders Diagnosed in Childhood
Aripiprazole
Aggression

Additional relevant MeSH terms:

Tranquilizing Agents
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