Recruiting

Epigenetic Markers

Sponsor:

Johns Hopkins University

Code:

NCT06771583

Conditions

PMDD

Premenstrual Dysphoric Disorder (PMDD)

Premenstrual Syndrome-PMS

Premenstrual Syndrome

Menstrual Cycle

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

PMDD

Premenstrual Dysphoric Disorder (PMDD)

Premenstrual Syndrome-PMS

Premenstrual Syndrome

Menstrual Cycle

Study ID

NCT06771583

Start date

Sep 12, 2025

Status verified date

May, 2026

Completion date

Feb 15, 2031

Anticipated

Primary completion date

Feb 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • female sex
  • regular menstrual cycles (24-35 days)
  • age 18-50 years
  • ability to give written informed consent

Exclusion Criteria:

  • psychiatric medication use in the past 2 months;
  • substance use disorder in the past 2 months (per MINI);
  • lifetime history of psychotic disorder including schizophrenia, schizoaffective disorder, major depression with psychotic features (per MINI);
  • history of psychiatric disorder other than PMDD in past year (per MINI);
  • active suicidal ideation with plan or attempt in past 6 months (per MINI);
  • steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months;
  • pregnancy in past 6 months;
  • history of brain injury;
  • current or history of endocrine disorder including uncontrolled diabetes or thyroid disease;
  • BMI>40.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 and Locations

Central contacts

Victoria Paone, B.S.

vpaone1@jh.edu

Locations

Johns Hopkins Reproductive Mental Health Center

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Principal Investigator:

Liisa Hantsoo, Ph.D.

More Information

Sponsor

Johns Hopkins University

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • menstrual cycle
  • pms
  • luteal phase
  • womens health
  • reproductive health
  • reproductive mental health
  • epigenetics
  • dna methylation
  • premenstrual
  • pmdd
  • women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-07.