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Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children (Abilify)

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ClinicalTrials.gov Identifier: NCT00468130
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : October 2, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 subscale.

(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 or disease Intervention/treatment
Autism Drug: Aripiprazole

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Study Start Date : May 2006
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Aripiprazole
Subjects in the experimental group will receive Aripiprazole
Drug: Aripiprazole
Subjects under 40 kg will be started on 2.5mg per day of aripiprazole or placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects
Other Name: Abilify
Placebo Comparator: Placebo
Subjects in the control group will receive placebo

Outcome Measures

Primary Outcome Measures :
  1. Clinical Global Impression Improvement (CGI-AD) [ Time Frame: Administered weekly ]
  2. Aberrant Behavior Checklist [ Time Frame: Administered weekly ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468130

United States, New Jersey
Department of Child and Adolescent Psychiatry, University Behavioral Health Care Building
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Sherie L. Novotny, MD Child and Adolescent Psychiatry, UMDNJ
More Information

Additional Information:
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).

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00468130     History of Changes
Other Study ID Numbers: 0220055441
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
Global autism severity

Additional relevant MeSH terms:
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs