Antipsychotics and Blood Vessel Function

NCT00585273 | Completed

• 2 other identifiers: 200703764University of Iowa GCRC #0740
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 cardiovascular function and metabolic complications.

Conditions

Bipolar Disorder; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Flow-mediated dilation

  % dilation of the brachial artery in response to 5 minutes of ischemia

  6 months

• Forearm vascular resistance

  % dilation of forearm blood vessels in response to pharmacological challenge measured using plethysmography

  6 months

Study Arms (2)

1

Incident users of antipsychotics.

2

Non-users of antipsychotics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Thirty patients, 18 - 50 years of age, who are being started on a first-line, second-generation, antipsychotic associated with weight gain (risperidone, olanzapine, or quetiapine) for the treatment of an affective or psychotic disorder, will be invited to participate. Participants must not have taken any of these antipsychotics or clozapine in the preceding three months. Another twenty psychiatric controls not taking antipsychotic medications will also be enrolled. Statistically, controls will serve primarily to compare changes in flow-mediated dilation over time rather than for direct comparison of variables between groups. Participation will be voluntary and initiated upon clinician or self-referral.

You may qualify if:

• years of age
• Being started on a first-line, second-generation, antipsychotic associated with weight gain (risperidone, olanzapine, or quetiapine) for the treatment of an affective or psychotic disorder -OR- psychiatric controls not taking antipsychotic medications will also be enrolled

Sponsors & Collaborators

• Jess G. Fiedorowicz: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Links

• Department Web-site

MeSH Terms

Conditions

Bipolar Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Jess G Fiedorowicz, M.D., Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: January 3, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available on 8/27/2019 for a period of at least three years.
• Access Criteria: Requests for data will be reviewed by Principal Investigator Jess Fiedorowicz for additional analyses provided a statistical analysis plan.

Locations

US (1)