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Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

This study has been completed.
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00337571
First received: June 13, 2006
Last updated: November 7, 2013
Last verified: November 2009
Results First Received: June 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Behavioral Symptoms
Autistic Disorder
Interventions: Drug: Aripiprazole
Drug: Placebo

  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
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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
Placebo No text entered.
Aripiprazole 5 mg No text entered.
Aripiprazole 10 mg No text entered.
Aripiprazole 15 mg No text entered.

Participant Flow:   Overall Study
    Placebo   Aripiprazole 5 mg   Aripiprazole 10 mg   Aripiprazole 15 mg
STARTED   52   53   59   54 
COMPLETED   38   44   49   47 
NOT COMPLETED   14   9   10   7 
Lack of Efficacy                3                0                0                0 
Adverse Event                4                5                8                4 
Withdrawal by Subject                2                2                1                0 
Lost to Follow-up                3                1                0                1 
Poor/noncompliance                1                1                1                1 
No longer met study criteria                1                0                0                0 
High Potassium level                0                0                0                1 



  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.
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Reporting Groups
  Description
Placebo No text entered.
Aripiprazole 5 mg No text entered.
Aripiprazole 10 mg No text entered.
Aripiprazole 15 mg No text entered.
Total Total of all reporting groups

Baseline Measures
   Placebo   Aripiprazole 5 mg   Aripiprazole 10 mg   Aripiprazole 15 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   53   59   54   218 
Age, Customized 
[Units: Participants]
         
6 to 12 years   35   44   45   42   166 
13 to 17 years   17   9   14   12   52 
Gender 
[Units: Participants]
         
Female   4   6   9   4   23 
Male   48   47   50   50   195 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian   3   1   2   0   6 
Native Hawaiian or Other Pacific Islander   0   0   0   1   1 
Black or African American   13   13   15   9   50 
White   35   37   41   42   155 
Other   1   2   1   2   6 
Race/Ethnicity, Customized 
[Units: Participants]
         
Hispanic/Latino   8   5   7   5   25 
Not Hispanic/Latino   44   48   52   49   193 
Weight Group 
[Units: Participants]
         
<40 kilograms   24   35   33   34   126 
≥40 kilograms   28   18   26   20   92 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 20.49  (4.777)   19.91  (6.124)   21.06  (6.649)   20.14  (6.033)   20.41  (5.933) 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 144.9  (18.82)   136.5  (14.66)   142.3  (17.87)   139.3  (17.24)   140.8  (17.38) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 45.6  (20.01)   38.9  (18.26)   44.8  (22.38)   42.2  (22.99)   42.9  (21.07) 


  Outcome Measures
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1.  Primary:   Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score   [ Time Frame: Week 8 ]

2.  Secondary:   Mean Clinical Global Impressions Improvement Scale (CGI-I) Score   [ Time Frame: Week 8 ]

3.  Secondary:   Number of Participants With Response at Week 8   [ Time Frame: Week 8 ]

4.  Secondary:   Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only)   [ Time Frame: Week 8 ]

5.  Secondary:   Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores   [ Time Frame: Week 8 ]

6.  Secondary:   Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S)   [ Time Frame: Week 8 ]

7.  Secondary:   Summary of Safety   [ Time Frame: continuously throughout the study ]

8.  Secondary:   Change From Baseline in Body Weight   [ Time Frame: Week 8 ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00337571     History of Changes
Other Study ID Numbers: CN138-179
Study First Received: June 13, 2006
Results First Received: June 3, 2009
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration