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Aripiprazole in Adolescents With Schizophrenia (APEX 239)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00102063
First received: January 19, 2005
Last updated: August 6, 2012
Last verified: August 2012
Results First Received: May 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Aripiprazole tablet, 10 mg
Drug: Aripiprazole tablet, 30 mg
Drug: Placebo tablet

  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
Participants were recruited from 101 centers in the United States, Europe, South America, the Caribbean, and South Africa between August 2004 and August 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened over a 4-week period.

Reporting Groups
  Description
Aripiprazole 10 mg/Day Group Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
Aripiprazole 30 mg/Day Group Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
Placebo Group Participants were given a single pill administered once daily

Participant Flow:   Overall Study
    Aripiprazole 10 mg/Day Group     Aripiprazole 30 mg/Day Group     Placebo Group  
STARTED     100     102     100  
COMPLETED     84     84     90  
NOT COMPLETED     16     18     10  
Lack of Efficacy                 5                 1                 1  
Adverse Event                 7                 4                 2  
Withdrawal by Subject                 4                 12                 5  
Lost to Follow-up                 0                 0                 1  
Protocol Violation                 0                 1                 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
Aripiprazole 10 mg/Day Group Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
Aripiprazole 30 mg/Day Group Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
Placebo Group Participants were given a single pill administered once daily
Total Total of all reporting groups

Baseline Measures
    Aripiprazole 10 mg/Day Group     Aripiprazole 30 mg/Day Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  100     102     100     302  
Age  
[units: years]
Mean ± Standard Deviation
  15.6  ± 1.3     15.4  ± 1.4     15.4  ± 1.4     15.5  ± 1.4  
Gender  
[units: participants]
       
Female     55     37     39     131  
Male     45     65     61     171  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     1     1  
Asian     16     12     15     43  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     17     11     6     34  
White     54     62     64     180  
More than one race     0     0     0     0  
Unknown or Not Reported     13     17     14     44  



  Outcome Measures
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1.  Primary:   Change in Positive and Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Baseline and Day 42 ]

2.  Secondary:   Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score   [ Time Frame: Baseline and Day 42 ]

3.  Secondary:   Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score   [ Time Frame: Baseline and Day 42 ]

4.  Secondary:   Change in Clinical Global Impression (CGI) Severity Score   [ Time Frame: Baseline and Day 42 ]

5.  Secondary:   Clinical Global Impression (CGI) Improvement Score   [ Time Frame: Baseline and Day 42 ]

6.  Secondary:   Change in Children’s Global Assessment Scale (CGAS) Score   [ Time Frame: Baseline and Day 42 ]

7.  Other Pre-specified:   Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score   [ Time Frame: Baseline and Day 42 ]

8.  Other Pre-specified:   Patients Achieving Remission   [ Time Frame: Baseline and Day 42 ]


  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: Margaretta Nyilas
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
phone: 609-452-5673
e-mail: Margaretta.nyilas@otsuka-us.com


No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00102063     History of Changes
Other Study ID Numbers: 31-03-239
Study First Received: January 19, 2005
Results First Received: May 11, 2012
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration