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Observational Study of Epigenetic Biomarkers in PMDD

This study is looking into how changes in your genes, called epigenetic biomarkers, might be linked to Premenstrual Dysphoric Disorder (PMDD). Researchers want to see if certain biomarkers, previously found in postpartum depression, also appear in women with PMDD. They will collect biological samples, like blood, and track your mood changes over about three months to compare women with PMDD to those without it. This will help them understand if these genetic markers are connected to PMDD and how your body responds to hormone changes during your menstrual cycle. The study is open to women aged 18 to 50 who have regular menstrual cycles and are not currently taking psychiatric medications.

Study design
This is an observational study aiming to enroll 500 women. It is not a treatment study, but rather looks for connections between genetic markers and PMDD.
What's involved
You would provide biological samples and have your mood changes monitored from enrollment until study completion, which is approximately 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until study completion, which is approximately 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06771583

Identification and Validation of Epigenetic Biomarkers of PMDD

Recruiting
Not specifiedAges 18–50Observational
Johns Hopkins University
~500 participants
Updated 2026-05-07 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of DNA Methylation Biomarkers (Comparing individuals with PMDD and controls)
Measured over From enrollment until study completion (approximately 3 months)

Conditions

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

Explore related trials

Premenstrual Dysphoric DisorderPremenstrual syndrome

NCT06771583

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Johns Hopkins Reproductive Mental Health Center

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Liisa Hantsoo, Ph.D. · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Victoria Seo, B.S.
[email protected]
302-464-8320‬
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Presence of DNA Methylation Biomarkers (Comparing individuals with PMDD and controls)From enrollment until study completion (approximately 3 months)

    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.