Exploring the link between menopause, depression, and heart health in women
The Comorbidity of Depression and Cardiovascular Disease in Midlife Women: Investigating Novel Biological Pathways of Risk
NA · University of North Carolina, Chapel Hill · NCT05570721
This study is trying to see if depression during menopause can affect heart health in women by testing how stress impacts their bodies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 44 Years to 55 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05570721 on ClinicalTrials.gov |
What this trial studies
This study investigates how depression during the perimenopausal phase may increase the risk of cardiovascular disease in women. It employs an experimental stress task to activate two physiological stress pathways, the renin-angiotensin-aldosterone system (RAAS) and the autonomic nervous system (ANS), to understand their relationship with depression and heart health. Participants will include perimenopausal women with mild to moderate depressive symptoms and healthy women without psychiatric history, who will undergo psychological assessments and dietary preparations before the stress test. The findings aim to provide insights into potential mechanisms linking these conditions and inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are women aged 44-55 in the late perimenopause phase with mild to moderate depressive symptoms.
Not a fit: Patients with severe depressive symptoms, bipolar disorder, or primary psychotic disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes for midlife women by identifying mechanisms to reduce cardiovascular risk associated with depression during menopause.
How similar studies have performed: Other studies have shown success in exploring the relationship between depression and cardiovascular disease, but this specific approach focusing on perimenopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Margo Nathan, MD — University of North Carolina, Chapel Hill
- Study coordinator: Margo Nathan, MD
- Email: margo_nathan@med.unc.edu
- Phone: 919-962-9908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Menopause, Depression, Heart Disease in Women, Stress