SchizophreniaNCT00501163
Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
An observational study of Schizophrenia and Cardiovascular Disease, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Cardiovascular Disease
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
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.
The exclusion criteria are: i) Any lifetime DSM-IV diagnoses of intravenous drug use or alcohol dependence, or if criteria for alcohol abuse were ever met, subject must have not met criteria for abuse within the last 12 months; ii) any history of hepatitis; iii) medications that can cause significant changes in hepatic function, glucose, or lipid metabolism, as determined by the investigator; iv) lipid lowering or glucose lowering medications; v) involuntary legal status (as per Missouri law); vi) pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Participants will be asked to do the following:
- 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.
- 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.
- 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.
- 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.
- 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.
Read the 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.
- Conditions
- Schizophrenia, Cardiovascular Disease
- Keywords
- Schizophrenia, Cardiovascular, Risk
- Medical subject headings
- Schizophrenia, Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Daniel W Haupt, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501163
- Sponsor's protocol ID
- 07-0574
- Status last verified
- Jun 2018
- First submitted
- 11 Jul 2007
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT00501163
- Acronym / sponsor ID
- 07-0574
- Conditions
- Schizophrenia, Cardiovascular Disease
- Keywords
- Schizophrenia, Cardiovascular, Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Aug 2007
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be asked to do the following:
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Haupt, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Cardiovascular Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.