Salsalate for Insulin Resistance in Schizophrenia
Study Details
Study Description
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 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 inflammatory markers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: salsalate
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.
|
Outcome Measures
Primary Outcome Measures
- Side Effects of Salsalate [6 weeks]
This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
DSM-IV TR diagnosis of schizophrenia or schizoaffective disorder
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Body Mass Index (BMI) greater than or equal to 27 kg/m2
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Participant will be judged to be clinically stable
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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.
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Participants must be judged competent to participate in the informed consent process and provide voluntary informed consent.
Exclusion Criteria:
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Individuals with aspirin allergy.
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Individuals with pre-existing tinnitus.
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Individual with anemia or thrombocytopenia.
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Individuals with ongoing infections.
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Individuals with history of autoimmune disease.
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Individuals with peptic ulcer disease or gastritis.
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Individuals with weight loss greater than 5% over the past 6 months.
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Individuals currently taking immunosuppressive drugs including corticosteroids.
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Individuals taking anti-diabetic agents.
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Individuals taking non-steroidal anti-inflammatory agents (other than low dose aspirin).
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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.
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Pregnant females.
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Individuals who meet DSM-IV TR criteria for alcohol or substance dependence (except nicotine) within the last 6 months.
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Individuals who meet DSM-IV TR criteria for alcohol or substance abuse (except nicotine) within the last month.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baltimore VA Medical Center | Baltimore | Maryland | United States | 21201 |
| 2 | Maryland Psychiatric Research Center | Baltimore | Maryland | United States | 21228 |
Sponsors and Collaborators
- University of Maryland, Baltimore
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Robert W Buchanan, MD, University of Maryland School of Medicine Maryland Psychiatric Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HP-00046612
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from August 2010 to August 2011 from multiple community mental health clinics. |
|---|---|
| Pre-assignment Detail | Participants were withdrawn from the trial if they had abnormal lab values or were found to have a diagnosis of diabetes. |
| Arm/Group Title | Salsalate |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Salsalate |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 10 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
10
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
46.9
(7.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
20%
|
| Male |
8
80%
|
| Region of Enrollment (participants) [Number] | |
| United States |
10
100%
|
Outcome Measures
| Title | Side Effects of Salsalate |
|---|---|
| Description | This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects who completed the study were analyzed. |
| Arm/Group Title | Salsalate |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 10 |
| Number [participants] |
3
30%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Salsalate | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Salsalate | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Salsalate | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Salsalate | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Limitations/Caveats
More Information
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.
Results Point of Contact
| Name/Title | Dr. Robert Buchanan, M.D. |
|---|---|
| Organization | Maryland Psychiatric Research Center |
| Phone | 410-402-7876 |
| rwbuchanan@mprc.umaryland.edu |
- HP-00046612