Antipsychotics and Blood Vessel Function
|ClinicalTrials.gov Identifier: NCT00585273|
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : December 4, 2015
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 cardiovascular function and metabolic complications.
|Condition or disease|
|Bipolar Disorder Schizophrenia|
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Cardiovascular Complications of First-line, Second-generation Antipsychotics|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
Incident users of antipsychotics.
Non-users of antipsychotics
- Flow-mediated dilation [ Time Frame: 6 months ]% dilation of the brachial artery in response to 5 minutes of ischemia
- Forearm vascular resistance [ Time Frame: 6 months ]% dilation of forearm blood vessels in response to pharmacological challenge measured using plethysmography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585273
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Jess G Fiedorowicz, M.D., Ph.D.||University of Iowa|