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NCT00585273 · ClinicalTrials.gov registry record
Antipsychotics and Blood Vessel Function
A clinical trial of Schizophrenia and Bipolar Disorder, sponsored by Jess G. Fiedorowicz.
- Completed
- Registry status
- 44
- Enrollment target
- 1
- Study location
NCT00585273 is a study of Schizophrenia and Bipolar Disorder that has completed, run by Jess G. Fiedorowicz. The registered enrollment target is 44 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00585273, a study of Schizophrenia and Bipolar Disorder, has completed, sponsored by Jess G. Fiedorowicz.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Over the last decade, second generation antipsychotics have been increasingly utilized. Since their introduction, however, atypical antipsychotics have been increasingly associated with significant metabolic complications including hyperlipidemia, insulin resistance/diabetes mellitus, and obesity. These metabolic complications increase the risk for cardiovascular disease in populations with an already elevated risk. The initial goal of the proposed study is to identify early signs of endothelial dysfunction and vascular disease in those treated with atypical antipsychotics. The identification of early signs of vascular disease may further link metabolic complications with any cardiovascular risk. Demonstration of changes in vascular function associated with atypical antipsychotics represents an important identifiable intermediate of more long-term cardiovascular risk. The second goal of the proposed study is to identify genetic factors that may be associated with the development of cardiovascular disease, which can later serve as a guide to predict risk. Accurate prediction of risk may facilitate the future development of an empirical, risk-based, individualized selection process for antipsychotic medications. Aim 1: To quantify the role of antipsychotic-induced metabolic complications on the development of vascular disease using measures of endothelial function. Hypothesis 1: Atypical antipsychotics will lead to greater impairments in endothelial function, evidenced by decreased flow-mediated dilation from baseline measures and compared with changes over time in controls. Medication-induced metabolic complications will be temporally associated with these impairments in endothelial function. Aim 2: To investigate the role of candidate pharmacogenetic polymorphisms with cardiovascular and metabolic complications of atypical antipsychotics. Hypothesis 2: Profiles of polymorphisms at receptors targeted by atypical antipsychotics will be associated with impaired c
Conditions Studied
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-09 |
| Est. Completion | 2014-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00585273
The ClinicalTrials.gov registry entry for NCT00585273 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (80% lower). The listed sponsor is Jess G. Fiedorowicz, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 0 interventions.
NCT00585273 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT00585273 about?
NCT00585273 is a clinical study titled "Antipsychotics and Blood Vessel Function". Over the last decade, second generation antipsychotics have been increasingly utilized. Since their introduction, however, atypical antipsychotics have been increasingly associated with significant metabolic complications including hyperlipidemia, insulin resistance/diabetes mellitus, and obesity. T...
What is the current status of trial NCT00585273?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2007-09. Estimated completion is 2014-12.
What conditions does trial NCT00585273 study?
This clinical trial studies the following conditions: Schizophrenia, Bipolar Disorder.
Who is sponsoring clinical trial NCT00585273?
This trial is sponsored by Jess G. Fiedorowicz, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00585273 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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