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Salsalate for the Treatment of Insulin Resistance in People With Schizophrenia
This study is currently Recruiting
November 2010 By University of Maryland
First Recieved on August 13, 2010
Last Updated on November 29, 2010
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 for developing type II diabetes. Approximately 15% of people with
schizophrenia have type II diabetes. People with type II diabetes have problems with their
body's insulin. Insulin is a hormone produced by the body to control blood sugar level.
Obesity and type II diabetes are strong risk factors for heart disease. In type II diabetes
the body does not respond to insulin correctly. Obesity, type II diabetes, and insulin
resistance are all common states of inflammation. Inflammation is a reaction by the body to
irritation, injury, or infection.
Salicylates are non-steroidal anti-inflammatory drugs. Aspirin is an example of a
salicylate. These drugs work by decreasing the level of inflammation in the body.
Salicylates have been shown to decrease inflammation and improve the body's response to
insulin. Improving the body's response to insulin and decreasing inflammation could
possibly reduce the risk of developing type II diabetes. Salicylates have been known for
years to be effective for the treatment of diabetes. Salicylates increase the body's
response to insulin causing blood sugar levels to decrease. Many salicylate drugs have side
effects including stomach irritation and increased risk of bleeding. The drug for this
study is called salsalate and is different from other salicylates. Salsalate has a lower
bleeding risk than aspirin. Salsalate has been used to treat arthritis and has been shown
to be safe.
There have been no studies using salsalate in people with schizophrenia. The purpose of
this study is to gain experience in the use of salsalate in people with schizophrenia. The
study would be a pilot study to obtain preliminary data. The study would be a 6-week study
where everyone in the study would receive the drug salsalate. The participants in the study
will have tests of baseline symptoms of schizophrenia, a physical exam, EKG (to check heart
function), and a side effect checklist for possible side effects from salsalate. The study
will also have some blood drawn to measure blood sugar levels, insulin levels, and
||Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
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.
Salsalate will be administered in 500 mg tablets. Salsalate will be administered in two divided doses of 2 grams in the morning and 2 grams in the evening. Salsalate will be administered for a total of 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 tolerated or a minimum dose of 2 grams per day is achieved.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- 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
- 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.
- Investigator: Robert W Buchanan, MD - Principal Investigator - University of Maryland School of Medicine Maryland Psychiatric Research Center
- Maryland Psychiatric Research Center
Baltimore, Maryland 21228 United States
- Baltimore VA Medical Center
Baltimore, Maryland 21201 United States