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Aripiprazole in Children and Adolescents With Bipolar I Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00110461
First Posted: May 10, 2005
Last Update Posted: May 21, 2012
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.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results First Submitted: August 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar 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
Participants were recruited from 59 centers in the United States between March 2005 and February 2007. A total of 413 subjects were screened for enrollment, with 296 subjects assigned to double-blind treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened over a 28-day period.

Reporting Groups
  Description
Aripiprazole 10 mg/Day 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 was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
Aripiprazole 30 mg/Day 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, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
Placebo Participants were given a single pill administered once daily.

Participant Flow for 2 periods

Period 1:   30-Week, Double-blind Treatment Phase
    Aripiprazole 10 mg/Day   Aripiprazole 30 mg/Day   Placebo
STARTED   98   99   99 
COMPLETED   34   22   12 
NOT COMPLETED   64   77   87 

Period 2:   Acute Phase
    Aripiprazole 10 mg/Day   Aripiprazole 30 mg/Day   Placebo
STARTED   98   99   99 
COMPLETED   84   77   76 
NOT COMPLETED   14   22   23 



  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 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 was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
Aripiprazole 30 mg/Day 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, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
Placebo Participants were given a single pill administered once daily.
Total Total of all reporting groups

Baseline Measures
   Aripiprazole 10 mg/Day   Aripiprazole 30 mg/Day   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   99   99   296 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.70  (2.17)   13.31  (2.32)   13.28  (2.12)   13.43  (2.21) 
Gender 
[Units: Participants]
       
Female   46   48   43   137 
Male   52   51   56   159 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   6   10   15   31 
Not Hispanic or Latino   92   89   84   265 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   2   0   0   2 
Black or African American   24   18   23   65 
White   65   68   60   193 
More than one race   2   2   2   6 
Unknown or Not Reported   5   11   14   30 
Height 
[Units: Centimeters (cm)]
Mean (Standard Deviation)
 161.05  (12.45)   158.37  (12.21)   158.69  (11.63)   159.36  (12.12) 
Weight 
[Units: Kilograms (kg)]
Mean (Standard Deviation)
 63.76  (20.11)   60.49  (21.50)   60.48  (17.31)   61.57  (19.71) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 24.15  (5.37)   23.66  (6.70)   23.68  (4.98)   23.83  (5.72) 
Young Mania Rating Scale Score (Y-MRS) [1] 
[Units: Points]
Mean (Standard Deviation)
 29.8  (6.5)   29.5  (6.3)   30.7  (6.8)   30.0  (6.5) 
[1] The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 defined grades of severity. Minimum score on the scale is 0 (absent or normal); maximum score on the scale is 60 (worse outcome or more severe symptoms).
Children's Depression Rating Scale - Revised (CDRS-R) Suicidal Ideation Score [1] 
[Units: Points]
Mean (Standard Deviation)
 1.1  (0.4)   1.1  (0.5)   1.2  (0.5)   1.2  (0.5) 
[1] The CDRS-R is used to diagnose depression and monitor treatment response. The interviewer rates 17 symptom areas (including those that sever as DSM-IV criteria for diagnosis of depression), among them suicidal ideation. Most of the 17 symptom areas are rated on a 7-point scale. The Suicide Ideation Score is rated on a 7-point scale, where the minimum score on the scale is 1 (better outcome) and the maximum score is 7 (worse outcome).
Treatment given for previous episodes 
[Units: Participants]
       
Yes   57   50   63   170 
No   41   49   36   126 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4   [ Time Frame: Baseline and Week 4 ]

2.  Secondary:   Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30   [ Time Frame: Baseline and Week 30 ]

3.  Secondary:   Change in Children’s Global Assessment Scale (CGAS) Total Score at Week 4   [ Time Frame: Baseline and Week 4 ]

4.  Secondary:   Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4   [ Time Frame: Baseline and Week 4 ]

5.  Secondary:   Change in Children’s Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4   [ Time Frame: Baseline and Week 4 ]

6.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4   [ Time Frame: Baseline and Week 4 ]

7.  Secondary:   Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4   [ Time Frame: Baseline and Week 4 ]

8.  Secondary:   Change in Children's Global Assessment (CGAS) Total Score at Week 30   [ Time Frame: Baseline and Week 30 ]

9.  Secondary:   Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30   [ Time Frame: Baseline and Week 30 ]

10.  Secondary:   Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4   [ Time Frame: Baseline and Week 4 ]

11.  Secondary:   Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30   [ Time Frame: Baseline and Week 30 ]

12.  Secondary:   Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4   [ Time Frame: Baseline and Week 4 ]

13.  Secondary:   Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30   [ Time Frame: Baseline and Week 30 ]

14.  Secondary:   Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30   [ Time Frame: Baseline and Week 30 ]

15.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30   [ Time Frame: Baseline and Week 30 ]

16.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4   [ Time Frame: Baseline and Week 4 ]

17.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30   [ Time Frame: Baseline and Week 30 ]

18.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4   [ Time Frame: Baseline and Week 4 ]

19.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30   [ Time Frame: Baseline and Week 30 ]

20.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4   [ Time Frame: Baseline and Week 4 ]

21.  Secondary:   Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30   [ Time Frame: Baseline and Week 30 ]

22.  Secondary:   Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30   [ Time Frame: Baseline and Week 30 ]

23.  Secondary:   Subject Response to Treatment at Week 4   [ Time Frame: Baseline and Week 4 ]

24.  Secondary:   Subject Response to Treatment at Week 30   [ Time Frame: Baseline and Week 30 ]

25.  Secondary:   Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4   [ Time Frame: Baseline and Week 4 ]

26.  Secondary:   Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30   [ Time Frame: Baseline and Week 30 ]

27.  Secondary:   Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4   [ Time Frame: Baseline and Week 4 ]

28.  Secondary:   Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30   [ Time Frame: Baseline and Week 30 ]

29.  Secondary:   Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4   [ Time Frame: Baseline and Week 4 ]

30.  Secondary:   Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30   [ Time Frame: Baseline and Week 30 ]


  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
Primary efficacy endpoint is change from baseline in Y-MRS total score. Only randomized subjects with both baseline and 1+ post-baseline were included in primary efficacy analysis so # randomized is different from # included in the efficacy analysis.


  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: Andy Forbes
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.
e-mail: andy.forbes@otsuka-us.com


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

Responsible Party: Arifulla Khan, MD, Northwest Clinical Research Center
ClinicalTrials.gov Identifier: NCT00110461     History of Changes
Other Study ID Numbers: 31-03-240
First Submitted: May 9, 2005
First Posted: May 10, 2005
Results First Submitted: August 11, 2011
Results First Posted: May 21, 2012
Last Update Posted: May 21, 2012