Actively Recruiting

Age: 18Years - 50Years
FEMALE
Healthy Volunteers
NCT06771583

Identification and Validation of Epigenetic Biomarkers of PMDD

Led by Johns Hopkins University · Updated on 2026-05-07

500

Participants Needed

1

Research Sites

283 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Identification and Validation of Epigenetic Biomarkers of PMDD

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female sex
  • Regular menstrual cycles lasting 24 to 35 days
  • Age between 18 and 50 years
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Use of psychiatric medications in the past 2 months
  • Substance use disorder in the past 2 months
  • History of psychotic disorders including schizophrenia or major depression with psychotic features
  • Psychiatric disorders other than PMDD in the past year
  • Active suicidal thoughts with plan or attempt in past 6 months
  • Use of steroid hormones or hormonal contraceptives (except levonorgestrel as emergency contraceptive) in past 2 months
  • Pregnancy in past 6 months
  • History of brain injury
  • Current or past endocrine disorders including uncontrolled diabetes or thyroid disease
  • Body mass index over 40

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Reproductive Mental Health Center

Baltimore, Maryland, United States, 21205

Actively Recruiting

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Research Team

V

Victoria Seo, B.S.

CONTACT

V

Victoria Paone, B.S.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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