Depression, Aging, Stress and Heart Health Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05570721
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
44 Years - 55 Years
Healthy Volunteers
Accepted

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 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.

Study Details

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.

Key Dates

Start date
Nov 16, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Women with perimenopausal depression
    Participants will undergo a social stress task (TSST)
  • Experimental: Women without perimenopausal depression
    Participants will undergo a social stress task (TSST)

Primary Outcome Measure

Salivary aldosterone (pg/mL) levels at rest (before the stress task). [ Time Frame: Immediately prior to the stress task. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Margo Nathan
[email protected]
[email protected]
Margo Nathan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
DepressionMenopause
By specialty
PsychiatryMental healthBehavioral healthWomen's healthFertility
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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