RecruitingNCT06771583

Identification and Validation of Epigenetic Biomarkers of PMDD


Sponsor

Johns Hopkins University

Enrollment

500 participants

Start Date

Sep 12, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for epigenetic markers (chemical changes to DNA that affect how genes are turned on or off) in women with Premenstrual Dysphoric Disorder (PMDD) — a severe form of PMS that causes significant mood and physical symptoms in the days before a period. The goal is to better understand the biology of PMDD. **You may be eligible if...** - You are female, aged 18–50 years - You have regular menstrual cycles (24–35 days) - You are able to provide written informed consent **You may NOT be eligible if...** - You used psychiatric medications in the past 2 months - You had a substance use disorder in the past 2 months - You have a lifetime history of psychotic disorder, major depression with psychosis, or schizophrenia - You had another psychiatric disorder in the past year - You have active suicidal ideation with a plan or history of a suicide attempt Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Johns Hopkins Reproductive Mental Health Center

Baltimore, Maryland, United States

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NCT06771583


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