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Could stress explain the link between depression and heart disease in menopause?

NCT ID NCT05570721

Knowledge-focused Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why depression and heart disease often occur together in women going through menopause. Researchers will measure stress-related chemicals and heart rate in 30 women aged 44-55. The goal is to find clues that could lead to better ways to reduce heart disease risk in this group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

44 to 55 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Depression depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Heart disease in women Menopause Stress

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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