Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
Condition: Schizophrenia; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Schizophrenia
Study type: Observational

Summary: 
      Participants will be asked to do the following:

        1. A screening session in which you will take part in a diagnostic interview that will take
           about 2-3 hours to complete and will address your medical history. If you've recently
           participated in one of Dr. Haupt's or Dr. Newcomer's studies (HRPO #03-1281, 01-0134, or
           04-0191) you may not have to complete this screening interview.

        2. An ultrasound test of your heart and blood vessels where an ultrasound machine will use
           sound waves to create images that allow the main blood vessels in your neck to be
           examined. You will be lying down for the procedure, and a colorless gel will be applied
           to the side of your neck where the handheld probe (called a transducer) will be placed.
           The transducer will then be gently moved over each side of your neck. This procedure
           will take approximately 30 minutes.

        3. A magnetic resonance image (MRI) study where the amount of fat in your liver will be
           measured. The MRI involves having your body painlessly scanned inside a tubular machine,
           while lying on a table for about 45 minutes.

        4. Some routine blood tests to assess glucose (sugar) and lipid (fat) control and liver
           function, as well as an additional hepatitis screen if you have a history of hepatitis.
           You will go to the Intensive Research Unit (IRU) or Clinical Trials Unit (CTU) after an
           8 to 10-hour overnight fast (except water). Approximately 42 ml (3 tablespoons) of blood
           will be obtained from you, and you will also have your height, weight, blood pressure,
           and waist and hip measurements taken. This will take approximately one hour.

        5. A dual energy x-ray absorptiometry (DEXA) scan to measure your body fat and body muscle
           content. The DEXA scan involves lying on a table in a private room wearing a hospital
           gown for about 15 minutes while a machine silently measures the amount of fat in your
           body. The DEXA scan is part of the research study and gives the researcher a picture of
           how much fat is in your body.
    

Detailed description: 
      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. This study uses
      established medical tests that can predict how you might be affected. 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.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The inclusion criteria for the schizophrenia/schizoaffective group are: i) aged 18-55
        years; ii) otherwise healthy and meets DSM-IV criteria for schizophrenia, any type, or
        schizoaffective disorder iii) able to give informed consent.

        The inclusion criteria for children are: i) age 10-18 years; ii) otherwise healthy and
        meets DSM-IV criteria for one or more childhood-onset psychiatric disorder iii) able to
        give assent and have a guardian able to provide informed consent.

        The inclusion criteria for the healthy controls are: aged 18-55 years; ii) otherwise
        healthy and do not meet DSM-IV criteria for any Axis I psychiatric illness; iii) able to
        give informed consent.
      
Keywords: Schizophrenia; Cardiovascular; Risk