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Direct, Noninvasive Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
This study is not yet open for participant recruitment.
Verified by Washington University School of Medicine, July 2007
Sponsors and Collaborators: Washington University School of Medicine
National Alliance for Research on Schizophrenia and Depression
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00501163
  Purpose

In comparison to the general population, major mental illness is associated with higher rates of heart disease, stroke, and diabetes. These problems can result in a life span that can be up to 25 years shorter than in people without a major mental illness. There are noninvasive ways (procedures that don’t use needles or require surgery) to predict these outcomes in research. Unfortunately, however, these procedures have not been used much in psychiatric research, even though there is growing evidence that major mental disorders are associated with significant risk of heart disease, stroke and diabetes. The purpose of this study is to compare the risk for these disorders in people with schizophrenia with the risk for these disorders in other people without schizophrenia. We hypothesize that people with schizophrenia will have more artery blockage than age- and body mass index (BMI)-matched people without schizophrenia, and that these age- and BMI-matched individuals will have more blockage than lean, young healthy adults.

Participants will be asked to do the following:

  1. A screening session in which participants will take part in a diagnostic interview that will take about 2-3 hours to complete and will address subjects' medical history.
  2. An ultrasound test of participants' heart and blood vessels where an ultrasound machine will use sound waves to create images that allow the main blood vessels in the neck to be examined. Participants will be lying down for the procedure, and a colorless gel will be applied to the side of their neck where the handheld probe (called a transducer) will be placed. The transducer will then be gently moved over each side of the neck. This procedure will take approximately 30 minutes.
  3. A magnetic resonance image (MRI) study where the amount of fat in subjects' liver will be measured. The MRI involves having the body painlessly scanned inside a tubular machine, while lying on a table for about 45 minutes.

Condition
Schizophrenia
Cardiovascular Disease

MedlinePlus related topics: Mental Health Schizophrenia
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title: Direct, Noninvasive Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients

Further study details as provided by Washington University School of Medicine:

Estimated Enrollment: 90
Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For schizophrenia group are:

  • Aged 18-45 years
  • Otherwise healthy and meets DSM-IV criteria for schizophrenia, any type, treated with a stable dose of an antipsychotic for at least 3 months
  • Able to give informed consent
  • No antipsychotic medication dose changes for 1 month, and no other medication changes for 1 month prior to study enrollment.

For the healthy controls are:

  • Aged 18-45 years
  • Otherwise healthy and do not meet DSM-IV criteria for any Axis I psychiatric illness
  • Able to give informed consent.

Exclusion Criteria:

  • Meets DSM-IV criteria for the diagnoses of substance abuse within the past 3 months
  • Involuntary legal status (as per Missouri law)
  • The presence of any serious medical disorder that may confound the assessment of relevant biologic measures or diagnosis, including: significant organ system dysfunction, metabolic diseases, type 1 or 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, anemia, or acute infection
  • Patients taking more than one antipsychotic medication
  • Subjects taking prescription medications (except certain psychotropic medications as discussed below), including oral contraceptive pills, any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501163

Contacts
Contact: Elizabeth Westerhaus, MA 314-747-1134 westerhe@psychiatry.wustl.edu
Contact: Julie Schweiger 314-362-3153 schweigj@psychiatry.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Daniel W Haupt, MD Washington University School of Medicine
  More Information

Study ID Numbers: 07-0574
Study First Received: July 11, 2007
Last Updated: July 11, 2007
ClinicalTrials.gov Identifier: NCT00501163  
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Schizophrenia
Cardiovascular
Risk

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009