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

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ClinicalTrials.gov Identifier: NCT00619190
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill

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
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Aripipraprazole no Medication Control
Hide Arm/Group 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.
Period Title: Overall Study
Started 21 9
Completed 20 9
Not Completed 1 0
Arm/Group Title Open Aripipraprazole no Medication Control Total
Hide Arm/Group 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. They may receive behavioral interventions Total of all reporting groups
Overall Number of Baseline Participants 21 9 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 9 participants 30 participants
<=18 years
21
 100.0%
9
 100.0%
30
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 9 participants 30 participants
8.269  (3.75) 11.11  (4.5) 9.542  (4.272)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 9 participants 30 participants
Female
2
   9.5%
1
  11.1%
3
  10.0%
Male
19
  90.5%
8
  88.9%
27
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 9 participants 30 participants
21 9 30
1.Primary Outcome
Title Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.
Arm/Group Title Open Aripipraprazole no Medication Control
Hide Arm/Group 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. They may receive behavioral interventions
Overall Number of Participants Analyzed 20 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.6  (9.7) -0.6  (0.50)
2.Secondary Outcome
Title Clinical Global Impressions Scale - Severity Score (CGI-S)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.
Arm/Group Title Open Aripipraprazole no Medication Control
Hide Arm/Group 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. They may receive behavioral interventions
Overall Number of Participants Analyzed 20 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.35  (0.74) 4.5  (0.85)
3.Secondary Outcome
Title Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available.
Arm/Group Title Open Aripipraprazole no Medication Control
Hide Arm/Group 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. They may receive behavioral interventions
Overall Number of Participants Analyzed 20 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.5  (6.4) -0.3  (2.4)
Time Frame Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Aripipraprazole no Medication Control
Hide Arm/Group 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. They may receive behavioral interventions
All-Cause Mortality
Open Aripipraprazole no Medication Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Aripipraprazole no Medication Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Open Aripipraprazole no Medication Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/21 (90.48%)      5/9 (55.56%)    
Ear and labyrinth disorders     
Vertigo  1  1/21 (4.76%)  1 0/9 (0.00%)  0
Gastrointestinal disorders     
Appetite Increased  1  4/21 (19.05%)  6 0/9 (0.00%)  0
Appetite Decreased  1  1/21 (4.76%)  1 0/9 (0.00%)  0
Abdominal pain  1  2/21 (9.52%)  3 0/9 (0.00%)  0
Encopresis  1  2/21 (9.52%)  3 0/9 (0.00%)  0
Diarrhea  1  3/21 (14.29%)  3 0/9 (0.00%)  0
General disorders     
Insomnia  1  5/21 (23.81%)  7 1/9 (11.11%)  1
Nightmares  1  0/21 (0.00%)  0 1/9 (11.11%)  2
Headache/Migraine  1  5/21 (23.81%)  5 0/9 (0.00%)  0
Immune system disorders     
Allergies  1  0/21 (0.00%)  0 2/9 (22.22%)  2
Infections and infestations     
Infection  1  7/21 (33.33%)  7 0/9 (0.00%)  0
Fever  1  1/21 (4.76%)  1 2/9 (22.22%)  2
Psychiatric disorders     
Agitation  1  2/21 (9.52%)  21 0/9 (0.00%)  0
Anxiety  1  2/21 (9.52%)  21 1/9 (11.11%)  1
Depression  1  1/21 (4.76%)  1 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders     
Mouth Sores  1  0/21 (0.00%)  0 1/9 (11.11%)  1
acne  1  2/21 (9.52%)  2 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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
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