Depression, Aging, Stress and Heart Health Study
Eligible age
44–55 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: University of North Carolina, Chapel Hill
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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:
- ✕ 1. Hormonal agents (e.g., hormone replacement therapy or combined oral contraceptive pills)within the past 30 days
- ✕ 2. Oral, inhaled, or injected steroids within the past 90 days
- ✕ 3. Blood pressure medications (e.g., Angiotensin-Converting Enzyme (ACE) inhibitors) within the past 90 days
Where it's recruiting
Chapel Hill
Source: ClinicalTrials.gov · NCT05570721 · last updated 2025-12-22