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
This trial accepts healthy volunteersQualifiers
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 population
Participants will be recruited from Virginia, Washington DC, and Maryland (Baltimore area).
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Presence of DNA Methylation Biomarkers (Comparing individuals with PMDD and controls)
In the luteal phase, DNA methylation variations at HP1BP3, TTC9B will distinguish controls from individuals with PMDD. In the follicular phase, DNA methylation variations at HP1BP3 and TTC9B will not distinguish controls from PMDD. The investigators will be collecting dried blood spots and assaying these epigenetic markers using various DNA methylation techniques.
Secondary outcomes
Presence of DNA Methylation Biomarkers (comparing history of SSRI treatment vs SSRI non response)
In the luteal phase, DNA methylation variations at HP1BP3, TTC9B will distinguish those with a history of SSRI treatment response versus SSRI non-response among women with PMDD. In the follicular phase, DNA methylation variations at HP1BP3, TTC9B will not distinguish those with a history of SSRI treatment response versus SSRI non-response among women with PMDD. Samples from which these assays are performed are from dried blood spots.
Epigenetic biomarkers associated with PMDD
Novel epigenetic biomarkers associated with PMDD will be identified using dried blood spots and associated methods and techniques for analysis.
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator