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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.
Full description
This study uses an experimental stress task to induce mild social stress and activation of two physiological stress pathways (the RAAS and ANS) that may be be involved in the association between perimenopausal depression and risk for cardiovascular disease in women. Perimenopausal women with mild-moderate depressive symptoms and healthy women without any psychiatric history will be enrolled. All participants will complete the same study procedures.
During the first visit (conducted remotely) consent will be obtained. After consent, participants will answer questions about their psychiatric history as part of a standardized psychological assessment (the Mini International Neuropsychiatric Interview) and medical/reproductive history, including current medications. They will also complete brief questionnaires about their current mood symptoms and history of exposure to trauma. Risk for self-harm using the Columbia Suicide Severity Rating Scale (CSSRS) will be assessed. After it is determined that a participant is eligible based on these assessments, she will then be given instruction for how to prepare for the second study visit, including refraining from exercise, alcohol, caffeine for at least 4 hours prior to the visit. Dietary education is also provided and participants are asked to keep a food journal for 3 days prior to the second study visit to standardize nutritional content prior to the second study visit.
During the second visit (conduced in-person in a laboratory setting) participants will complete a brief stress task. All of these visits will be conducted between 2-6 in the afternoon/evening.This visit will have four components:
Sample collection: blood and saliva will be collected immediately prior to and following the stress task. Saliva is also collected at 10 and 20 minutes after the stress task. Heart rate will be measured through the duration of the stress task and recovery period.
The third visit includes a brief telephone call with the principal investigator to review participation in the study and answer any questions.
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Inclusion criteria
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:
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
Primary purpose
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Interventional model
Masking
30 participants in 2 patient groups
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Central trial contact
Margo Nathan, MD
Data sourced from clinicaltrials.gov
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