RecruitingNot ApplicableNCT05570721

Depression, Aging, Stress and Heart Health Study

The Comorbidity of Depression and Cardiovascular Disease in Midlife Women: Investigating Novel Biological Pathways of Risk

Sponsor

University of North Carolina, Chapel Hill

Enrollment

30 participants

Start Date

Nov 16, 2022

Study Type

INTERVENTIONAL

Conditions

Menopause Depression Stress Heart Disease in Women

Summary

Depression is a known risk factor for cardiovascular disease (CVD), and this comorbidity contributes significantly to the morbidity and mortality of women. The menopausal transition or perimenopause is a period of vulnerability for both depression and CVD, making it a key time to study this critical public health issue. This research will preliminarily explore whether disruption in two novel stress pathways 1) the renin-angiotensin-aldosterone system (RAAS) and autonomic nervous system (ANS) and their relationship may underlie the link between these illnesses. Findings will provide important insight into potential mechanisms by which depression during perimenopause may increase risk for CVD in midlife women, which will inform potential risk reduction and treatment strategies that can improve health outcomes in this population.

Eligibility

Sex: FEMALEMin Age: 44 YearsMax Age: 55 Years

Inclusion Criteria2

Women ages 44-55 in the late perimenopause reproductive phase. Perimenopausal status will be determined based on menstrual cycle history. We will enroll women who have had an interval of amenorrhea of at least 60 days but \<1 year consistent with the late menopause transition
Participants in either group may be on antidepressant medications (for any indication), but doses must be stable within 30 days of study participation

Exclusion Criteria12

History of bipolar diagnosis or primary psychotic disorder for both groups; prior history of depression in the no-perimenopausal depression group
In the perimenopausal depression group, current depressive symptoms that are "severe" based on score of Center for Epidemiologic Studies Depression Scale (CES-D) \>25.
Current alcohol or substance use disorder
Current suicidal ideation with intent and history of suicide attempt within 2 years of study participation
Current or recent use of the following medications:
Hormonal agents (e.g., hormone replacement therapy or combined oral contraceptive pills)within the past 30 days
Oral, inhaled, or injected steroids within the past 90 days
Blood pressure medications (e.g., Angiotensin-Converting Enzyme (ACE) inhibitors) within the past 90 days
Antihistamines within the past two weeks
Other medications determined by the study team to impact the RAAS (e.g., spironolactone).
Current cigarette or nicotine use
Current diagnosis of cardiovascular disease, type I or II diabetes, or other medical condition which the study team determines could impact study outcomes

Interventions

BEHAVIORALTrier Social Stress Test

The TSST has both social-evaluative and arithmetic components. During the social-evaluative component, the participant is asked to prepare and then deliver a brief speech to the research team. After this component there is a surprise arithmetic problem. This challenge paradigm has been well-established to rapidly and robustly induce psychological stress as well as physiological indices of stress (e.g., cortisol response, heart rate response). This task takes approximately 15 minutes to complete.