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

Plain Language Summary

Simplified for easier understanding

This study is examining the connection between depression, stress, and heart health in women going through perimenopause (the transition leading up to menopause). Researchers want to better understand how mood changes during this life stage may affect the heart. **You may be eligible if...** - You are a woman between ages 44–55 in the late stages of perimenopause (you have had at least 60 days without a period but less than 1 full year) - You may be on antidepressant medications as long as the dose has been stable for 30 days **You may NOT be eligible if...** - You have a history of bipolar disorder or psychotic disorder - You are in the non-depression group and have a prior history of depression - You have severe current depression symptoms (high score on a standard depression scale) - You have significant heart or other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.