Antipsychotics and Blood Vessel Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
Jess G. Fiedorowicz, University of Iowa
ClinicalTrials.gov Identifier:
NCT00585273
First received: December 19, 2007
Last updated: December 19, 2012
Last verified: December 2012

December 19, 2007
December 19, 2012
September 2007
December 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00585273 on ClinicalTrials.gov Archive Site
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Antipsychotics and Blood Vessel Function
Cardiovascular Complications of First-line, Second-generation Antipsychotics

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Bipolar Disorder
  • Schizophrenia
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  • 1
    Incident users of risperidone, quetiapine, or olanzapine.
  • 2
    Non-users of second generation antipsychotics
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-50 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

Exclusion Criteria:

  • Exclusion criteria will include the presence of any of the following: neoplasm, active thyroid disease (i.e. not euthyroid), pregnancy or planned pregnancy, diabetes mellitus, Raynaud's disease, anticoagulant therapy, or inability to provide informed consent. We will exclude participants who have started valproic acid derivatives in the preceding 6 months, given its association with insulin resistance and weight gain. Participants with active substance abuse or dependence will also be excluded.
Both
18 Years to 50 Years
No
Contact: Lois Warren, B.S.W. (319) 353-4523 lois-warren@uiowa.edu
Contact: Jess G Fiedorowicz, M.D., Ph.D. (319) 353-4333 jess-fiedorowicz@uiowa.edu
United States
 
NCT00585273
200703764, University of Iowa GCRC #0740
No
Jess G. Fiedorowicz, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Jess G Fiedorowicz, M.D., M.S. University of Iowa
University of Iowa
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP