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A Multicenter, Placebo-controlled, Double-blind Investigative Extension Trial of the Safety and Efficacy of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00606177
First received: January 19, 2008
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: November 28, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar I 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
Aripiprazole

Patients who had completed the preceding study and demonstrated drug efficacy were the target.

Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days.

Placebo

Patients who had completed the preceding study and demonstrated drug efficacy were the target.

Subjects were administered placebo once daily for 154 days.


Participant Flow:   Overall Study
    Aripiprazole   Placebo
STARTED   55   44 
COMPLETED   28   19 
NOT COMPLETED   27   25 
Adverse Event                9                5 
Lack of Efficacy                3                7 
Physician Decision                1                0 
Protocol Violation                1                4 
Withdrawal by Subject                5                6 
Progression to depressive phase                6                1 
Diabetic blood glucose level/ High HbA1c                1                1 
Change of residence or other commitments                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.

Full Analysis Population(FAS):Excluding 3 subject with GCP violation from the randomized subjects.

(Aripiprazole:1, Placebo:2)


Reporting Groups
  Description
Aripiprazole

Patients who had completed the preceding study and demonstrated drug efficacy were the target.

Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days.

Placebo

Patients who had completed the preceding study and demonstrated drug efficacy were the target.

Subjects were administered placebo once daily for 154 days.

Total Total of all reporting groups

Baseline Measures
   Aripiprazole   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   42   96 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.7  (11.95)   37.8  (11.67)   38.3  (11.78) 
Age 
[Units: Participants]
     
<=18 years   0   1   1 
Between 18 and 65 years   54   41   95 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   29   24   53 
Male   25   18   43 
Region of Enrollment 
[Units: Participants]
     
Taiwan   4   9   13 
China   9   9   18 
Japan   22   10   32 
Malaysia   4   6   10 
Indonesia   5   2   7 
Philippines   10   6   16 


  Outcome Measures
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1.  Primary:   Young Mania Rating Scale (YMRS)   [ Time Frame: Baseline (Day 1 of preceding study) , Day 154 or at discontinuation ]

2.  Secondary:   Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness (Mania)   [ Time Frame: Baseline (Day 1 of preceding study), Day 154 or at discontinuation ]


  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: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
phone: +81-3-6361-7366



Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00606177     History of Changes
Other Study ID Numbers: 031-06-004
Study First Received: January 19, 2008
Results First Received: November 28, 2013
Last Updated: January 16, 2014