Actively Recruiting

Phase Not Applicable
Age: 44Years - 55Years
FEMALE
Healthy Volunteers
NCT05570721

Depression, Aging, Stress and Heart Health Study

Led by University of North Carolina, Chapel Hill · Updated on 2025-12-22

30

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

F

Foundation of Hope, North Carolina

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Depression, Aging, Stress and Heart Health Study

Who Can Participate

Age: 44Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 44 to 55 years in the late perimenopause reproductive phase, defined by menstrual cycle history with at least 60 days but less than 1 year of amenorrhea
  • Participants may be on antidepressant medications if doses have been stable for at least 30 days prior to participation
Not Eligible

You will not qualify if you...

  • History of bipolar disorder or primary psychotic disorder
  • Prior history of depression in the non-perimenopausal depression group
  • Current severe depressive symptoms in the perimenopausal depression group (CES-D score >25)
  • Current alcohol or substance use disorder
  • Current suicidal ideation with intent or suicide attempt within the past 2 years
  • Use of hormonal agents within the past 30 days
  • Use of oral, inhaled, or injected steroids within the past 90 days
  • Use of blood pressure medications within the past 90 days
  • Use of antihistamines within the past 2 weeks
  • Use of other medications impacting the RAAS as determined by the study team
  • Current cigarette or nicotine use
  • Current diagnosis of cardiovascular disease, type I or II diabetes, or other medical conditions affecting study outcomes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

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Research Team

M

Margo Nathan, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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