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Search / Trial NCT05570721

Depression, Aging, Stress and Heart Health Study

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Oct 5, 2022

Trial Information

Current as of May 23, 2025

Recruiting

Keywords

ClinConnect Summary

The Depression, Aging, Stress and Heart Health Study is researching how depression during the menopausal transition affects heart health in women. This study is particularly focused on women aged 44 to 55 who are experiencing late perimenopause, a time when their menstrual cycles are changing and they may face increased risks for both depression and heart disease. Researchers want to understand how stress and certain body systems might connect these two health issues, which could help in finding better ways to protect women's heart health during this important life stage.

To participate in this study, women need to be within the specified age range and in the late perimenopause phase, meaning they haven’t had a period for at least 60 days but less than a year. They can be on stable doses of antidepressants, but they should not have severe depression or certain other medical conditions, like cardiovascular disease or diabetes. Participants will undergo assessments related to their mental and physical health, which could lead to new insights about managing depression and heart disease in women. This study is currently recruiting participants, and those interested should reach out to find out more about joining.

Gender

FEMALE

Eligibility criteria

  • 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:
  • 1. Hormonal agents (e.g., hormone replacement therapy or combined oral contraceptive pills)within the past 30 days
  • 2. Oral, inhaled, or injected steroids within the past 90 days
  • 3. Blood pressure medications (e.g., Angiotensin-Converting Enzyme (ACE) inhibitors) within the past 90 days
  • 4. Antihistamines within the past two weeks
  • 5. Other medications determined by the study team to impact the RAAS (e.g., spironolactone).
  • 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

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Chapel Hill, North Carolina, United States

Patients applied

AG

1 patients applied

Trial Officials

Margo Nathan, MD

Principal Investigator

University of North Carolina, Chapel Hill

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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