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

Primary Purpose

Autistic Disorder, Asperger Syndrome, Autism Spectrum Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring open label, aripiprazole, children, adolescents, autism spectrum disorders

Eligibility Criteria

30 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

open aripipraprazole

no medication control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2008
Last Updated
February 7, 2014
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00619190
Brief Title
Study of Aripiprazole to Treat Children and Adolescents With Autism
Acronym
PAIRS
Official Title
An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Asperger Syndrome, Autism Spectrum Disorder
Keywords
open label, aripiprazole, children, adolescents, autism spectrum disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open aripipraprazole
Arm Type
Experimental
Arm Description
Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
Arm Title
no medication control
Arm Type
No Intervention
Arm Description
group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Other Intervention Name(s)
Abilify
Intervention Description
aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
Primary Outcome Measure Information:
Title
Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks
Description
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.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Scale - Severity Score (CGI-S)
Description
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).
Time Frame
Baseline to 12 weeks
Title
Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks
Description
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.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linmarie Sikich, MD
Organizational Affiliation
University of North Carolina, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina, Department of Psychiatry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

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Study of Aripiprazole to Treat Children and Adolescents With Autism

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