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Study of Aripiprazole in Patients With Schizophrenia- Effects on Glucose Metabolism-

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00392197
First received: October 24, 2006
Last updated: December 19, 2013
Last verified: December 2013
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Aripiprazole

  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
Antipsychotic-naïve Patients Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
Patients Previously Treated With Antipsychotic Drugs Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent

Participant Flow:   Overall Study
    Antipsychotic-naïve Patients   Patients Previously Treated With Antipsychotic Drugs
STARTED   48   63 
COMPLETED   27   33 
NOT COMPLETED   21   30 
Adverse Event                4                12 
Lack of Efficacy                3                4 
Lost to Follow-up                0                1 
Physician Decision                3                2 
Protocol Violation                7                5 
Withdrawal by Subject                4                6 



  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.

The glucose metabolism analysis set.

The numbers of excluded subjects from the data of partcipant flow were:

  • violation of inclusion/exclusion criteria: naïve arm- 4, prior treated arm- 1
  • no data of blood glucose level after treatment: naïve arm- 3, prior treated arm- 2

Reporting Groups
  Description
Antipsychotic-naïve Patients Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
Patients Previously Treated With Antipsychotic Drugs Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
Total Total of all reporting groups

Baseline Measures
   Antipsychotic-naïve Patients   Patients Previously Treated With Antipsychotic Drugs   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   58   101 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.2  (13.6)   39.9  (14.0)   35.7  (14.6) 
Age 
[Units: Participants]
     
<=18 years   6   0   6 
Between 18 and 65 years   36   54   90 
>=65 years   1   4   5 
Gender 
[Units: Participants]
     
Female   22   29   51 
Male   21   29   50 
Region of Enrollment 
[Units: Participants]
     
Japan   43   58   101 


  Outcome Measures
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1.  Primary:   Fasting Blood Glucose (FBS) Level (if Fasting Blood Glucose Level Was Not Available, Non-fasting Blood Glucose (Non-FBS) Level)   [ Time Frame: Prior to the start of administration (Baseline) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or discontinuation ]

2.  Secondary:   HbA1c   [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52, or 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: NCT00392197     History of Changes
Other Study ID Numbers: 031-05-002-C
JapicCTI-060325
Study First Received: October 24, 2006
Results First Received: December 19, 2013
Last Updated: December 19, 2013