Salsalate for Insulin Resistance in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier:
NCT01182727
First received: August 13, 2010
Last updated: May 7, 2013
Last verified: May 2013

August 13, 2010
May 7, 2013
August 2010
November 2011   (final data collection date for primary outcome measure)
Side Effects of Salsalate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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.
Side Effects of Salsalate [ Time Frame: every week during a six week study ] [ Designated as safety issue: Yes ]
Side Effect Checklist to monitor common medication side effects
Complete list of historical versions of study NCT01182727 on ClinicalTrials.gov Archive Site
Not Provided
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.
Not Provided
Not Provided
 
Salsalate for Insulin Resistance in Schizophrenia
Salsalate for the Treatment of Insulin Resistance in People With 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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Insulin Resistance
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.
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.
Intervention: Drug: salsalate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01182727
HP-00046612
Yes
Robert W. Buchanan, M.D., University of Maryland
University of Maryland
Department of Veterans Affairs
Principal Investigator: Robert W Buchanan, MD University of Maryland School of Medicine Maryland Psychiatric Research Center
University of Maryland
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP