Identification and Validation of Epigenetic Biomarkers of PMDD

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• female sex

• regular menstrual cycles (24-35 days)

• age 18-50 years

• ability to give written informed consent

Locations
United States
Maryland
Johns Hopkins Reproductive Mental Health Center
RECRUITING
Baltimore
Contact Information
Primary
Liisa Hantsoo, Ph.D.
lhantso1@jhmi.edu
215-645-7035
Backup
Victoria Seo, B.S.
vseo1@gmail.com
302-464-8320‬
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2031-02-15
Participants
Target number of participants: 500
Treatments
Control
Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms.
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.
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov