Identification and Validation of Epigenetic Biomarkers of PMDD
Recruiting · NCT06771583 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Johns Hopkins Reproductive Mental Health Center - Baltimore, Maryland, United States