Salsalate for Insulin Resistance in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier:
NCT01182727
First received: August 13, 2010
Last updated: May 7, 2013
Last verified: May 2013
Results First Received: January 28, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Insulin Resistance
Intervention: Drug: salsalate

  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
Participants were recruited from August 2010 to August 2011 from multiple community mental health clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were withdrawn from the trial if they had abnormal lab values or were found to have a diagnosis of diabetes.

Reporting Groups
  Description
Salsalate Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.

Participant Flow:   Overall Study
    Salsalate  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  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
Salsalate Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.

Baseline Measures
    Salsalate  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.9  ± 7.4  
Gender  
[units: participants]
 
Female     2  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Side Effects of Salsalate   [ Time Frame: 6 weeks ]


  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: Dr. Robert Buchanan, M.D.
Organization: Maryland Psychiatric Research Center
phone: 410-402-7876
e-mail: rwbuchanan@mprc.umaryland.edu


No publications provided


Responsible Party: Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier: NCT01182727     History of Changes
Other Study ID Numbers: HP-00046612
Study First Received: August 13, 2010
Results First Received: January 28, 2013
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board