Depression, Aging, Stress and Heart Health Study for Women in Perimenopause

This study is looking at the link between depression, stress, and heart health in women going through perimenopause (the time leading up to menopause). Researchers want to understand if changes in stress pathways, specifically the renin-angiotensin-aldosterone system (RAAS) and autonomic nervous system (ANS), play a role in why depression and heart disease often occur together during this time. You would participate in a behavioral intervention called the Trier Social Stress Test, which involves giving a short speech and doing a math problem. The study will measure levels of salivary and plasma aldosterone (a hormone related to stress) before and after this stress task. They are looking for women aged 44-55 who are in late perimenopause, with or without mild to moderate depressive symptoms. The study aims to enroll 30 participants.

Study design: This is an interventional study involving 30 women. It compares women with mild-moderate depressive symptoms to healthy women without psychiatric history.
What's involved: You would have a remote first visit for consent and assessments, followed by a second in-person visit for the stress task and measurements. You would need to avoid exercise, alcohol, and caffeine for at least 4 hours before the second visit.
Compensation: Not stated in the trial record.
Follow-up: Salivary and plasma aldosterone levels are measured immediately prior to the stress task and at intervals of 0, 10, and 20 minutes after the stress task.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Depression, Aging, Stress and Heart Health Study

Recruiting

NAAges 44–55Interventional

University of North Carolina, Chapel Hill

~30 participants

Updated 2025-12-22 on ClinicalTrials.gov

What's tested:Trier Social Stress Test

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Salivary aldosterone (pg/mL) levels at rest (before the stress task).

Measured over Immediately prior to the stress task.

+7 more outcomes measured

Conditions

Menopause

Depression

Heart Disease in Women

Stress

NCT05570721

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of North Carolina at Chapel Hill
Chapel Hill, North Carolinastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Margo Nathan, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Margo Nathan, MD

[email protected]

919-962-9908

Email the study team

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Eligibility criteria

Inclusion

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

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:

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

What this trial measures

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.
Change in plasma angiotensin II (pg/mL) levels in response to the stress task.Immediately prior to and at 0 minutes after the stress task.
Examine variability in plasma angiotensin II levels (pg/mL) in response to the TSST.
Plasma renin (pg/mL/hr) levels at rest (before the stress task).Immediately prior to the stress task.
Examine variability in plasma renin levels (pg/mL/hr) by calculating medians.
Change in plasma renin (pg/mL/hr) levels in response to the stress taskImmediately prior to and at 0 minutes after the stress task
Examine variability in plasma renin levels (pg/mL/hr) in response to the TSST.

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