Epigenetic markers linked to PMDD across the menstrual cycle
Identification and Validation of Epigenetic Biomarkers of PMDD
Johns Hopkins University · NCT06771583
This study tests whether blood epigenetic markers can tell apart women with PMDD from women without PMDD at different points in the menstrual cycle.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06771583 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood samples and mood ratings from women with PMDD and from control women across the follicular and luteal phases of their menstrual cycles. Investigators will measure DNA methylation biomarkers previously linked to postpartum depression and use a repeated-measures approach to see if these markers vary by diagnosis and cycle phase. A secondary aim compares biomarkers between PMDD participants who have responded to SSRI treatment and those who have not. Eligible participants are women 18–50 with regular 24–35 day cycles who meet medication and health criteria.
Who should consider this trial
Good fit: Women aged 18–50 with regular menstrual cycles who either have PMDD or do not have PMDD and who meet the study's medication and health criteria.
Not a fit: Women using steroid hormones or hormonal contraceptives, those with recent psychiatric medication or substance use disorders, recent pregnancy, uncontrolled endocrine disease, very high BMI, or recent major psychiatric illness are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If validated, these biomarkers could enable a blood test to identify hormone sensitivity and help guide diagnosis and treatment choices for PMDD.
How similar studies have performed: The investigators previously reported an epigenetic biomarker that predicted postpartum depression with over 80% accuracy and a small cross-sectional PMDD cohort showed the biomarker distinguished cases from controls in the luteal phase.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Reproductive Mental Health Center — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Liisa Hantsoo, Ph.D. — Johns Hopkins University
- Study coordinator: Victoria Seo, B.S.
- Email: vseo1@jh.edu
- Phone: 302-464-8320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PMDD, Premenstrual Dysphoric Disorder, Premenstrual Syndrome-PMS, Premenstrual Syndrome, Menstrual Cycle, menstrual cycle, pms, luteal phase