Actively Recruiting
Identification and Validation of Epigenetic Biomarkers of PMDD
Led by Johns Hopkins University · Updated on 2026-05-07
500
Participants Needed
1
Research Sites
52 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
Researchers are studying premenstrual dysphoric disorder (PMDD), a mood disorder linked to hormone changes during the menstrual cycle. This research aims to identify epigenetic markers, which are biological signs in the DNA, that may help distinguish individuals with PMDD from those without symptoms. The study focuses on understanding how these markers vary between the follicular phase (first half) and luteal phase (second half) of the menstrual cycle, building on previous findings related to postpartum depression. The study involves two groups of female participants aged 18 to 50 years: those without premenstrual mood symptoms and those with PMDD or severe premenstrual syndrome symptoms. Participants will collect blood samples at home using a dried blood spot system during both menstrual phases. The study also compares epigenetic markers between women with PMDD who have responded to selective serotonin reuptake inhibitor (SSRI) treatment and those who have not. Participants will be involved for about three months, during which their mood changes and biological samples will be collected and analyzed. The main outcome measured is the presence of DNA methylation biomarkers linked to PMDD and treatment response. This observational study monitors participants' natural menstrual cycles and mood, with no treatment assigned, to better understand biological differences related to PMDD.
CONDITIONS
Brief Title
Identification and Validation of Epigenetic Biomarkers of PMDD
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- Use of psychiatric medication 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
- History of 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 emergency contraceptives) in the past 2 months
- Pregnancy in the past 6 months
- History of brain injury
- Current or past endocrine disorders including uncontrolled diabetes or thyroid disease
- Body mass index (BMI) greater than 40
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 3 months
Participants provide blood samples at home during both the follicular and luteal phases of their menstrual cycles to assess epigenetic biomarkers related to hormone sensitivity and PMDD.
Repeated home blood sample collections during menstrual cycles
Trial Site Locations
Total: 1 location
1
Johns Hopkins Reproductive Mental Health Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
V
Victoria Seo, B.S.
V
Victoria Paone, B.S.
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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