Salsalate for Insulin Resistance in Schizophrenia
Condition: Schizophrenia; Insulin Resistance
MeSH terms: Insulin Resistance; Schizophrenia
Study type: Interventional

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.
    


Intervention name(s): salsalate
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Salicylsalicylic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; salsalate; obesity