Salsalate for Insulin Resistance in Schizophrenia
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Purpose
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 | Intervention |
|---|---|
|
Schizophrenia Insulin Resistance |
Drug: salsalate |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Salsalate for the Treatment of Insulin Resistance in People With Schizophrenia |
- Side Effects of Salsalate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Side Effect Checklist to monitor common medication side effects
- Efficacy of Salsalate [ Time Frame: 6 weeks at the completion of the study ] [ Designated as safety issue: No ]The following laboratory analysis will be performed: fasting glucose, insulin and lipid levels; insulin C peptide; HgbA1c; and high sensitivity CRP. The fasting glucose and insulin levels will be used to complete the homeostatic model assessment for insulin resistance (HOMA-IR). The following inflammatory markers and cytokines will be evaluated: IL-1B, IL-1RA, IL-2, IL-6, IL-10, TNF-alpha, and adiponectin.
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| Contact: Amy Morrison | (410) 402-6060 | amorrison@mprc.umaryland.edu |
| Contact: William Keller, MD | 410 (402)-6898 | wkeller@mprc.umaryland.edu |
| United States, Maryland | |
| Maryland Psychiatric Research Center | Recruiting |
| Baltimore, Maryland, United States, 21228 | |
| Principal Investigator: Robert W Buchanan, MD | |
| Baltimore VA Medical Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: Robert W Buchanan, MD | |
| Principal Investigator: | Robert W Buchanan, MD | University of Maryland School of Medicine Maryland Psychiatric Research Center |
More Information
No publications provided
| Responsible Party: | Robert W. Buchanan, M.D., University of Maryland School of Medicine Maryland Psychiatric Research Center |
| ClinicalTrials.gov Identifier: | NCT01182727 History of Changes |
| Other Study ID Numbers: | HP-00046612 |
| Study First Received: | August 13, 2010 |
| Last Updated: | November 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Maryland:
|
schizophrenia salsalate obesity |
Additional relevant MeSH terms:
|
Insulin Resistance Schizophrenia Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Schizophrenia and Disorders with Psychotic Features Mental Disorders Sodium Salicylate Salicylsalicylic acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on October 17, 2012
