Depression, Aging, Stress and Heart Health Study

What this trial studies

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.

Conditions in scope

• Menopause
• Depression
• Heart Disease in Women
• Stress

Interventions

• Trier Social Stress Test (Behavioral) — 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…

Who can join

Women only · Ages 44 Years to 55 Years · Accepts healthy volunteers.

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2022-11-16
• Primary completion: 2026-06-30
• Last update posted: 2025-12-22
• First posted: 2022-10-07

Sponsor & contact

Lead sponsor: University of North Carolina, Chapel Hill (Other)

Collaborators: Foundation of Hope, North Carolina

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Salivary aldosterone (pg/mL) levels at rest (before the stress task). (Immediately prior to the stress task.)
  Examine variability in salivary aldosterone levels (pg/mL) by calculating medians.
• Change in salivary aldosterone (pg/mL) levels in response to the stress task. (Immediately prior to the stress task and at intervals of 0, 10, and 20 minutes after the stress task.)
  Examine variability in salivary aldosterone levels (pg/mL) in response to the TSST.
• Plasma aldosterone (pg/mL) levels at rest (before the stress task). (Immediately prior to the stress task.)
  Examine variability in plasma aldosterone levels (pg/mL) by calculating medians.
• Change in plasma aldosterone (pg/mL) levels in response to the stress task. (Immediately prior to and at 0 minutes after the stress task.)
  Examine variability in plasma aldosterone levels (pg/mL) in response to the TSST.
• Plasma angiotensin II (pg/mL) levels at rest (before the stress task). (Immediately prior to the stress task.)
  Examine variability in plasma angiotensin II levels (pg/mL) by calculating medians.

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