Identification and Validation of Epigenetic Biomarkers of PMDD

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06771583
Status
Recruiting
Apply to this trial

Conditions

  • Menstrual Cycle
  • PMDD
  • Premenstrual Dysphoric Disorder (PMDD)
  • Premenstrual Syndrome
  • Premenstrual Syndrome-PMS

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Study Details

This research is being done to examine epigenetic markers and mood changes across the menstrual cycle, particularly in premenstrual dysphoric disorder (PMDD). The investigators previously identified epigenetic biomarkers of postpartum depression, another reproductive affective disorder, and in this study aim to determine if these biomarkers also distinguish PMDD cases from healthy controls at different points in the menstrual cycle. By collecting biological samples (such as blood) and monitoring mood changes across the menstrual cycle, the investigators will be able to determine whether these epigenetic markers are associated with PMDD. The investigators plan to study these epigenetic markers during the follicular phase (roughly the first half of the menstrual cycle, from menses until ovulation) and the luteal phase (roughly the second half of the menstrual cycle, from ovulation to menses). The investigators will study this in two groups: 1) individuals who do NOT have premenstrual mood symptoms, and 2) individuals with premenstrual syndrome/premenstrual dysphoric disorder (PMS/PMDD). The results will provide a comprehensive view of the changes in these systems across the menstrual cycle. This will add to the investigators understanding of the mechanisms that may cause PMS/PMDD.

Key Dates

Start date
Sep 12, 2025
Status verified
May 2026
Primary completion
Feb 15, 2030
Completion
Feb 15, 2031

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Control
    Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms.
  • Arm: Premenstrual Dysphoric Disorder (PMDD)
    Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria.

Primary Outcome Measure

Presence of DNA Methylation Biomarkers (Comparing individuals with PMDD and controls) [ Time Frame: From enrollment until study completion (approximately 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Reproductive Mental Health CenterBaltimoreMaryland21205
Liisa Hantsoo, Ph.D.
[email protected]
215-435-3171
Victoria Seo, B.S.
[email protected]
302-464-8320‬
Liisa Hantsoo, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Reproductive Mental Health Center· Baltimore, MD

Related Studies