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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00619190
First Posted: February 20, 2008
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
Results First Submitted: September 16, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Autistic Disorder
Asperger Syndrome
Autism Spectrum Disorder
Intervention: Drug: aripiprazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Open Aripipraprazole Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
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.

Participant Flow:   Overall Study
    Open Aripipraprazole   no Medication Control
STARTED   21   9 
COMPLETED   20   9 
NOT COMPLETED   1   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open Aripipraprazole Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
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. They may receive behavioral interventions
Total Total of all reporting groups

Baseline Measures
   Open Aripipraprazole   no Medication Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   9   30 
Age 
[Units: Participants]
     
<=18 years   21   9   30 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.269  (3.75)   11.11  (4.5)   9.542  (4.272) 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   19   8   27 
Region of Enrollment 
[Units: Participants]
     
United States   21   9   30 


  Outcome Measures
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1.  Primary:   Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks   [ Time Frame: Baseline to 12 weeks ]

2.  Secondary:   Clinical Global Impressions Scale - Severity Score (CGI-S)   [ Time Frame: Baseline to 12 weeks ]

3.  Secondary:   Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks   [ Time Frame: Baseline to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linmarie Sikich, MD
Organization: UNC Chapel Hill
phone: 919-972-7499
e-mail: lsikich@med.unc.edu



Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00619190     History of Changes
Other Study ID Numbers: 04-1792 GCRC-2491
First Submitted: February 7, 2008
First Posted: February 20, 2008
Results First Submitted: September 16, 2013
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014