Epigenetic markers linked to PMDD across the menstrual cycle

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.