Identification and Validation of Epigenetic Biomarkers of PMDD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorJohns Hopkins University

About this trial

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

Qualifiers

female sex

regular menstrual cycles (24-35 days)

age 18-50 years

ability to give written informed consent

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator