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Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment

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.
ClinicalTrials.gov Identifier: NCT00337350
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : March 6, 2013
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Schizophrenia
Interventions: Drug: rosiglitazone
Drug: placebo

  Participant Flow

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

Participant Flow:   Overall Study
    Rosiglitazone   Placebo
STARTED   9   11 
COMPLETED   8   10 

  Baseline Characteristics

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
Rosiglitazone rosiglitazone 4mg/day
Placebo matched placebo for rosiglitazone 4mg/day
Total Total of all reporting groups

Baseline Measures
   Rosiglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   11   20 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   9   11   20 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 41.11  (10.29)   39.36  (7.06)   40.15  (8.46) 
[Units: Participants]
Female   2   3   5 
Male   7   8   15 
Region of Enrollment 
[Units: Participants]
United States   9   11   20 

  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

  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.

  More Information

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

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


Responsible Party: David C. Henderson, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00337350     History of Changes
Other Study ID Numbers: 2003-P-000014
First Submitted: June 13, 2006
First Posted: June 15, 2006
Results First Submitted: December 19, 2012
Results First Posted: March 6, 2013
Last Update Posted: May 8, 2015