Study Background and Objectives: In the U.S. the majority of heart disease deaths are in women, not men. Much of the gender disparity in cardiovascular disease (CVD) rates relate to the burden of cardiovascular risk in women after the menopause. Depression has been associated with an increased risk for CVD morbidity and mortality. Even histories of recurrent depression in individuals currently free of depression are associated with elevated cardiovascular risk. Understanding the depression-CVD link may have particular relevance for women since women experience depression at a rate twice that of men. Substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one likely mechanism contributing to both CVD and depression in women. The perimenopause, a time associated with a two-fold increase in rates of depression, may provide an ideal opportunity for studying the causes of elevated CVD risk and depression in women.
The primary objective of this study is to examine the protective role of estradiol in the development of depressive symptoms and the progression of cardiovascular risk in perimenopausal women with or without histories of depression. This study, funded by the National Institutes of Health, is a 12 month, randomized, placebo-controlled trial designed to examine the efficacy of transdermal estradiol (100 ug/day) for measures of CVD risk and depression.
We predict that women susceptible to depression will be particularly vulnerable to the acceleration of CVD in the context of the perimenopause and, consequently, will show differentially greater benefit of estradiol treatment during the menopause transition for both indices of cardiovascular risk (e.g. inflammation, endothelial function, stress reactivity), as well as depressive symptoms.
The PERT study is approved by the UNC Institutional Review Board, IRB #10-0542 and has been approved since 4/11/10 with the last renewal 3/04/11.
Please see http://www.psychiatry.unc.edu/wmd/research/perimenopausal-research-studies or www.pertstudy.com for more information.