No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
44 – 55
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
30 (estimated)
Sponsor
University of North Carolina, Chapel Hill · Other
Who this trial is looking for
This trial is looking for women aged 44 to 55 who are in the late perimenopause phase. Participants will help researchers understand how depression and stress may affect heart health during this time.
Are You a Good Fit for This Trial?
Must not be takingHormonal agentsBlood pressure medicationsSteroidsAntihistamines
Rules you outType 1 diabetesType 2 diabetes
You may be able to join if
I am a woman aged 44-55
I am in the late perimenopause phase
I have had no menstrual periods for at least 60 days
I am stable on my antidepressant medications for at least 30 days
You may not be able to join if
I have a history of bipolar diagnosis or primary psychotic disorder
I currently have severe depressive symptoms
I have a current alcohol or substance use disorder
I have current suicidal thoughts or a history of suicide attempt in the past 2 years
I have used hormonal agents in the past 30 days
I have used blood pressure medications in the past 90 days
I currently smoke or use nicotine
I have a current diagnosis of cardiovascular disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 stres…
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.
Trial Locations
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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
…
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
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