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Official title Depression, Aging, Stress and Heart Health Study
ClinicalTrials.gov ID: NCT05570721
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 44 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- Women ages 44-55 in the late perimenopause reproductive phase. Perimenopausal status will be determined based on menstrual cycle history. We will...
- Participants in either group may be on antidepressant medications (for any indication), but doses must be stable within 30 days of study participation
You likely can't join if
- 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...
- 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:
- Hormonal agents (e.g., hormone replacement therapy or combined oral contraceptive pills)within the past 30 days
See the full eligibility 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...
- 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:
- Hormonal agents (e.g., hormone replacement therapy or combined oral contraceptive pills)within the past 30 days
- Oral, inhaled, or injected steroids within the past 90 days
- Blood pressure medications (e.g., Angiotensin-Converting Enzyme (ACE) inhibitors) within the past 90 days
- Antihistamines within the past two weeks
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 44 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.