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Identification and Validation of Epigenetic Biomarkers of PMDD

Johns Hopkins University · with National Institute of Mental Health (NIMH) · NCT06771583

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–50 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
500
US sites recruiting
1
Study start
September 12, 2025
Record last updated
May 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Johns Hopkins Reproductive Mental Health Center

    Baltimore, MD 21205

    Site contact: Liisa Hantsoo, Ph.D. · 215-435-3171 · lhantso1@jhmi.edu

Study contacts (from the official record)

  • Victoria Seo, B.S. · 302-464-8320‬ · vseo1@jh.edu
  • Victoria Paone, B.S. · vpaone1@jh.edu
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Identification and Validation of Epigenetic Biomarkers of PMDD (NCT06771583) | Bored Studies