Salsalate for Insulin Resistance in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salsalate

Drug

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.

Primary outcomes

Side Effects of Salsalate

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

US Department of Veterans Affairs

Registry information

Official study title

Salsalate for the Treatment of Insulin Resistance in People With Schizophrenia

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Aug 17, 2010
Registry last updated: Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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