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

NCT00468130 | Completed Results

• 1 other identifier: 0220055441
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Aggression; Irritability; Global autism severity

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Improvement (CGI-AD)

  Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is not deemed clinically significant. Administration time is approximately 2 minutes. Minimum is 1 and maximum is 5. A lower score indicates improvement, whereas a higher score indicates worsening.

  Administered weekly, initial and week 8 reported

Secondary Outcomes (1)

• Aberrant Behavior Checklist

  Administered biweekly, initial and week 8 reported

Study Arms (2)

Aripiprazole

EXPERIMENTAL

Subjects in the experimental group will receive Aripiprazole

Drug: Aripiprazole

Placebo

PLACEBO COMPARATOR

Subjects in the control group will receive sugar pill

Drug: Placebos

Interventions

Aripiprazole DRUG

Subjects under 40 kg will be started on 2.5mg per day of aripiprazole 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

Also known as: Abilify

Aripiprazole

Placebos DRUG

Inactive tablet made to resemble active tablet Subjects under 40 kg will be started on 2.5mg per day of 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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

Department of Child and Adolescent Psychiatry, University Behavioral Health Care Building

Piscataway, New Jersey, 08854, United States

Location

Related Publications (2)

• 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).

  BACKGROUND

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

Related Links

• Official site of the Division of Child and Adolescent Psychiatry

MeSH Terms

Conditions

Autistic Disorder; Aggression

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sherie Novotny, MD
• Organization: Rutgers University

novotnsl@ubhc.rutgers.edu

7322354119

Study Officials

• Sherie L. Novotny, MD

  Child and Adolescent Psychiatry, UMDNJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 30, 2007
• First Posted: May 2, 2007
• Study Start: May 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)