RECRUITING

Depression, Aging, Stress and Heart Health Study

Conditions

Menopause Depression Heart Disease in Women Stress

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Comorbidity of Depression and Cardiovascular Disease in Midlife Women: Investigating Novel Biological Pathways of Risk

Quick Facts

Study Start:2022-11-16

Study Completion:2024-10-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05570721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:44 Years to 55 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Margo Nathan, MD

CONTACT

919-962-9908

margo_nathan@med.unc.edu

Principal Investigator

Margo Nathan, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-16

Study Completion Date2024-10-05

Study Record Updates

Study Start Date2022-11-16

Study Completion Date2024-10-05

Terms related to this study

Additional Relevant MeSH Terms

Menopause
Depression
Heart Disease in Women
Stress