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;   Endpoint Classification: Safety/Efficacy Study;   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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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  
Number of Participants  
[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


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Director of Clinical Research and Development
Organization: Otsuka Pharmaceutical Co., Ltd.
phone: +81-3-6361-7366


No publications provided


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
Health Authority: Japan: Ministry of Health, Labor and Welfare