Status:
COMPLETED
Salsalate for Insulin Resistance in Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Schizophrenia
Insulin Resistance
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Being obese is a common problem for people with schizophrenia. People with schizophrenia are more likely to be overweight compared to the general population. Being overweight is a major risk factor fo...
Eligibility Criteria
Inclusion
- DSM-IV TR diagnosis of schizophrenia or schizoaffective disorder
- Body Mass Index (BMI) greater than or equal to 27 kg/m2
- Participant will be judged to be clinically stable
- Participants will be treated with the same antipsychotic for at least 90 days and will have received a constant therapeutic dose for at least 20 days prior to study entry. There will not be any restriction on the type of antipsychotic with which the participant is treated.
- Participants must be judged competent to participate in the informed consent process and provide voluntary informed consent.
Exclusion
- Individuals with aspirin allergy.
- Individuals with pre-existing tinnitus.
- Individual with anemia or thrombocytopenia.
- Individuals with ongoing infections.
- Individuals with history of autoimmune disease.
- Individuals with peptic ulcer disease or gastritis.
- Individuals with weight loss greater than 5% over the past 6 months.
- Individuals currently taking immunosuppressive drugs including corticosteroids.
- Individuals taking anti-diabetic agents.
- Individuals taking non-steroidal anti-inflammatory agents (other than low dose aspirin).
- Individuals with organic brain disorder; mental retardation; or medical conditions whose pathology or treatment would alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol.
- Pregnant females.
- Individuals who meet DSM-IV TR criteria for alcohol or substance dependence (except nicotine) within the last 6 months.
- Individuals who meet DSM-IV TR criteria for alcohol or substance abuse (except nicotine) within the last month.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01182727
Start Date
August 1 2010
End Date
December 1 2011
Last Update
March 11 2022
Active Locations (2)
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1
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
2
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228