Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Stanley Medical Research Institute
Information provided by (Responsible Party):
David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00337350
First received: June 13, 2006
Last updated: January 30, 2013
Last verified: January 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Schizophrenia
Interventions: Drug: rosiglitazone
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
Subjects were recruited from the Freedom Trial Clinic at the Erich Lindemann Mental Health Center and were studied at the Mallinckrodt General Clinical Research Center (GCRC) at Massachusetts General Hospital (MGH), Boston.

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
Rosiglitazone rosiglitazone 4mg/day
Placebo matched placebo for rosiglitazone 4mg/day

Participant Flow:   Overall Study
    Rosiglitazone     Placebo  
STARTED     9     11  
COMPLETED     8     10  
NOT COMPLETED     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
Rosiglitazone rosiglitazone 4mg/day
Placebo matched placebo for rosiglitazone 4mg/day
Total Total of all reporting groups

Baseline Measures
    Rosiglitazone     Placebo     Total  
Number of Participants  
[units: participants]
  9     11     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     11     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.11  ± 10.29     39.36  ± 7.06     40.15  ± 8.46  
Gender  
[units: participants]
     
Female     2     3     5  
Male     7     8     15  
Region of Enrollment  
[units: participants]
     
United States     9     11     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Insulin Sensitivity   [ Time Frame: baseline, week 8 ]

2.  Primary:   Change From Baseline on Glucose Utilization (SG)   [ Time Frame: baseline, week 8 ]

3.  Primary:   Change From Baseline in Acute Insulin Response to Glucose (AIRG)   [ Time Frame: baseline, week 8 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Our findings in this study were limited by the small sample size. It is possible that with a larger sample, significant improvements might be observed not only in glucose metabolism but also in lipid metabolism.  


Results Point of Contact:  
Name/Title: Dr. David Henderson
Organization: Massachusetts General Hospital Schizophrenia Research Program
phone: (617) 912-7800
e-mail: dchenderson@partners.org


Publications:


Responsible Party: David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00337350     History of Changes
Other Study ID Numbers: 2003-P-000014
Study First Received: June 13, 2006
Results First Received: December 19, 2012
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board