RECRUITING

Identification and Validation of Epigenetic Biomarkers of PMDD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Identification and Validation of Epigenetic Biomarkers of PMDD

Quick Facts

Study Start:2025-09-12
Study Completion:2031-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06771583

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * female sex
  2. * regular menstrual cycles (24-35 days)
  3. * age 18-50 years
  4. * ability to give written informed consent
  1. * psychiatric medication use in the past 2 months;
  2. * substance use disorder in the past 2 months (per MINI);
  3. * lifetime history of psychotic disorder including schizophrenia, schizoaffective disorder, major depression with psychotic features (per MINI);
  4. * history of psychiatric disorder other than PMDD in past year (per MINI);
  5. * active suicidal ideation with plan or attempt in past 6 months (per MINI);
  6. * steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months;
  7. * pregnancy in past 6 months;
  8. * history of brain injury;
  9. * current or history of endocrine disorder including uncontrolled diabetes or thyroid disease;
  10. * BMI\>40.

Contacts and Locations

Study Contact

Liisa Hantsoo, Ph.D.
CONTACT
215-645-7035
lhantso1@jhmi.edu
Victoria Seo, B.S.
CONTACT
302-464-8320‬
vseo1@gmail.com

Principal Investigator

Liisa Hantsoo, Ph.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Reproductive Mental Health Center
Baltimore, Maryland, 21205
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Liisa Hantsoo, Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-12
Study Completion Date2031-02-15

Study Record Updates

Study Start Date2025-09-12
Study Completion Date2031-02-15

Terms related to this study

Keywords Provided by Researchers

  • menstrual cycle
  • pms
  • luteal phase
  • womens health
  • reproductive health
  • reproductive mental health
  • epigenetics
  • dna methylation
  • premenstrual
  • pmdd
  • women

Additional Relevant MeSH Terms

  • PMDD
  • Premenstrual Dysphoric Disorder (PMDD)
  • Premenstrual Syndrome-PMS
  • Premenstrual Syndrome
  • Menstrual Cycle