Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients
Recruitment status was Recruiting
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| First Received Date ICMJE | July 11, 2007 | ||||||||
| Last Updated Date | March 16, 2010 | ||||||||
| Start Date ICMJE | August 2007 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00501163 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients | ||||||||
| Official Title ICMJE | Direct Measurements of Cardiometabolic Risk in Treated Schizophrenia Patients | ||||||||
| Brief Summary | Participants will be asked to do the following:
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||||||
| Ages | 10 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00501163 | ||||||||
| Other Study ID Numbers ICMJE | 07-0574 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Daniel Haupt, MD, Washington University School of Medicine | ||||||||
| Study Sponsor ICMJE | Washington University School of Medicine | ||||||||
| Collaborators ICMJE | National Alliance for Research on Schizophrenia and Depression | ||||||||
| Investigators ICMJE |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | March 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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