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

This trial accepts healthy volunteers

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 population

Participants will be recruited from Virginia, Washington DC, and Maryland (Baltimore area).

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Control
Group B: Premenstrual Dysphoric Disorder (PMDD)

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment until study completion (approximately 3 months)

Secondary outcomes

1

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.

Time frame
From enrollment until study completion (approximately 3 months)
2

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.

Time frame
From enrollment until study completion (approximately 3 months)

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator