Study of Aripiprazole to Treat Children and Adolescents With Autism (PAIRS)

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00619190
First received: February 7, 2008
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Autistic Disorder
Asperger Syndrome
Autism Spectrum Disorder
Drug: aripiprazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impressions Scale - Severity Score (CGI-S) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

    One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).

    The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients).


  • Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.


Enrollment: 30
Study Start Date: January 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open aripipraprazole
Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
Drug: aripiprazole
aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
Other Name: Abilify
No Intervention: no medication control
group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.

Detailed Description:

The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.

  Eligibility

Ages Eligible for Study:   30 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619190

Locations
United States, North Carolina
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Bristol-Myers Squibb
Investigators
Principal Investigator: Linmarie Sikich, MD University of North Carolina, Department of Psychiatry
  More Information

No publications provided

Responsible Party: Linmarie Sikich, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00619190     History of Changes
Other Study ID Numbers: 04-1792 GCRC-2491
Study First Received: February 7, 2008
Results First Received: September 16, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
open label
aripiprazole
children
adolescents
autism spectrum disorders

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014