Study of Aripiprazole to Treat Children and Adolescents With Autism

NCT00619190 | Completed Phase 2 Results

• 1 other identifier: 04-1792 GCRC-2491
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.

Conditions

Autistic Disorder; Asperger Syndrome; Autism Spectrum Disorder

Keywords

open label; aripiprazole; children; adolescents; autism spectrum disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks

  The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.

  Baseline to 12 weeks

Secondary Outcomes (2)

• Clinical Global Impressions Scale - Severity Score (CGI-S)

  Baseline to 12 weeks

• Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks

  Baseline to 12 weeks

Study Arms (2)

open aripipraprazole

EXPERIMENTAL

Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg

Drug: aripiprazole

no medication control

NO INTERVENTION

group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.

Interventions

aripiprazole DRUG

aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months

Also known as: Abilify

open aripipraprazole

Eligibility Criteria

• Age: 30 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
• Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
• Have a guardian who is able and willing to give written informed consent
• If competent, subject able and willing to give written assent for their own participation
• If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
• Subjects may receive other nonpharmacologic treatment including dietary treatments

You may not qualify if:

• Diagnosis of Rett's syndrome or Child Disintegrative Disorder
• Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
• Previous trial of aripiprazole
• Pregnant or nursing
• Epilepsy or another significant chronic medical illness

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of North Carolina, Department of Psychiatry

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Asperger Syndrome; Autism Spectrum Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

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: Linmarie Sikich, MD
• Organization: UNC Chapel Hill

lsikich@med.unc.edu

919-972-7499

Study Officials

• Linmarie Sikich, MD

  University of North Carolina, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 20, 2008
• Study Start: January 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-02

Locations

US (1)