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
  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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Enrollment: 13
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: November 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182727

Locations
United States, Maryland
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
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., Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT01182727     History of Changes
Other Study ID Numbers: HP-00046612
Study First Received: August 13, 2010
Results First Received: January 28, 2013
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
schizophrenia
salsalate
obesity

Additional relevant MeSH terms:
Schizophrenia
Insulin Resistance
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
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 19, 2014