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
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
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.
No text entered.

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  
Number of Participants  
[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
  Show All Outcome Measures

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


  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.


Limitations and Caveats
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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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:

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