Depression, Aging, Stress and Heart Health Study

NCT05570721 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Trier 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.

Sponsors & Collaborators

  • The Foundation of Hope for Research and Treatment of Mental Illness

    collaborator UNKNOWN
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
44 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570721 on ClinicalTrials.gov