Depression, Aging, Stress and Heart Health Study
Recruiting · NCT05570721 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of North Carolina at Chapel Hill - Chapel Hill, North Carolina, United States