Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00222807 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : August 28, 2017
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Tracking Information | ||||
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First Submitted Date | September 13, 2005 | |||
First Posted Date | September 22, 2005 | |||
Last Update Posted Date | August 28, 2017 | |||
Study Start Date | August 2003 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures | Not Provided | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus | |||
Official Title | Schizophrenia, Antipsychotic Treatment and the Risk for Diabetes Mellitus | |||
Brief Summary | This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls. Regardless the treatment status, we collect the same neuroendocrine-immune data on the participants after 2 months. |
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Detailed Description | This preliminary study aims to investigate the mechanism of higher rates of type 2 diabetes mellitus in patients with schizophrenia. As part of the study, we collect neuroendocrine-immune data on patients with first episode, treatment naive psychosis, patients with newly diagnosed schizophrenia and normal healthy controls. Regardless the treatment status, we collect the same neuroendocrine-immune on the participants (patients and controls) after 2 months. Thus, our study does not control treatment. Patients take treatment in consultation with their physician. Some of them even decide not to take any medications. At the 2nd visit, we do ask them about the the medications they are taking if any. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: blood samples are collected, stored at minus 70 degree C and analyzed in batches.
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Sampling Method | Probability Sample | |||
Study Population | Patients with psychosis | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment |
200 | |||
Original Enrollment |
120 | |||
Actual Study Completion Date | March 2016 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 14 Years to 50 Years (Child, Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00222807 | |||
Other Study ID Numbers | 0306110 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Pittsburgh | |||
Study Sponsor | University of Pittsburgh | |||
Collaborators |
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Investigators |
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PRS Account | University of Pittsburgh | |||
Verification Date | March 2016 |