The Immunobiological Mechanisms of Depression in Perimenopause
Public ClinicalTrials.gov record NCT07910552. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This project aims to identify immunobiological mechanisms underlying the development of depression during the perimenopause. During the perimenopause, the risk for recurrence of depression is increased 13-fold among women who previously had depression. Moreover, perimenopause overlaps with the age span exhibiting the highest suicide rate for women. The perimenopause can last for several years and starts when estrogen and progesterone levels begin to fluctuate, gradually declining. Sex hormones are powerful modulators of the immune response and the investigators therefore propose that changes in lymphocytes play a central role in depression during this time. Notably, our previous work has demonstrated deficient regulatory T-cell responses in women with post- partum depression and identified a specific pro-inflammatory profile that predicts depression during pregnancy. Importantly, our new pilot data derived from women with severe depression in the perimenopausal age span reveals alterations in tryptophan metabolites that control T- cell responses as well as in the methylation of genes involved in T-cell fate and chromatin remodeling. Taken together, these data support the hypothesis that the perimenopausal hormonal shifts induce a pro-inflammatory state, regulated by chromatin modifications in T-cells, that triggers depression in vulnerable women. To test this hypothesis, the investigators will enroll 180 perimenopausal women aged 40-55, approximately half with depression and half without a diagnosis of depression. All participants will complete psychiatric assessments and provide blood samples to measure sex hormones, inflammation and immune cell changes. Women with depression will be reassessed approximately eight weeks later to identify blood markers that change as depressive symptoms improve. This project seeks to improve understanding of the biological mechanisms of depression during perimenopause and aid the development of predictive biomarkers and more effective treatments.
Study identification
- NCT ID
- NCT07910552
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 40 Years to 55 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 13, 2025 (Actual)
- Primary completion
- Nov 30, 2029 (Estimated)
- Completion
- Nov 30, 2031 (Estimated)
- Last update posted
- Nov 2, 2026
2025 – 2031
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Van Andel Institute | Grand Rapids | Michigan | 49503 | Active, not recruiting |
| Pine Rest Christian Mental Health | Grand Rapids | Michigan | 49548 | Recruiting |
| Western Michigan University Homer Stryker M.D. School of Medicine | Kalamazoo | Michigan | 49048 | Recruiting |
| Weill Cornell Medicine | New York | New York | 10065 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07910552, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2026 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07910552 live on ClinicalTrials.gov.