NCT06771583 Identification and Validation of Epigenetic Biomarkers of PMDD
| NCT ID | NCT06771583 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | PMDD |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-09-12 |
| Primary Completion | 2030-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-09-12 with a primary completion date of 2030-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Liisa Hantsoo, Ph.D.
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT06771583 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying PMDD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06771583 currently recruiting?
Yes, NCT06771583 is actively recruiting participants. Contact the research team at vseo1@jh.edu for enrollment information.
Where is the NCT06771583 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06771583 clinical trial?
NCT06771583 is sponsored by Johns Hopkins University. The principal investigator is Liisa Hantsoo, Ph.D. at Johns Hopkins University. The trial plans to enroll 500 participants.