Identification and Validation of Epigenetic Biomarkers of PMDD

NCT06771583 | Recruiting

• 2 other identifiers: IRB004844101R01MH135896
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presence of DNA Methylation Biomarkers (Comparing individuals with PMDD and controls)

  In the luteal phase, DNA methylation variations at HP1BP3, TTC9B will distinguish controls from individuals with PMDD. In the follicular phase, DNA methylation variations at HP1BP3 and TTC9B will not distinguish controls from PMDD. The investigators will be collecting dried blood spots and assaying these epigenetic markers using various DNA methylation techniques.

  From enrollment until study completion (approximately 3 months)

Secondary Outcomes (2)

• Presence of DNA Methylation Biomarkers (comparing history of SSRI treatment vs SSRI non response)

  From enrollment until study completion (approximately 3 months)

• Epigenetic biomarkers associated with PMDD

  From enrollment until study completion (approximately 3 months)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Virginia, Washington DC, and Maryland (Baltimore area).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins Reproductive Mental Health Center

Baltimore, Maryland, 21205, United States

RECRUITING

Related Links

• The study information and a link to the screening form will be on this page following IRB approval.

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder; Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Liisa Hantsoo, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liisa Hantsoo, Ph.D.

CONTACT

215-645-7035; lhantso1@jhmi.edu

Victoria Seo, B.S.

CONTACT

302-464-8320‬; vseo1@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): February 15, 2030
• Study Completion (Estimated): February 15, 2031
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)