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Identification and Validation of Epigenetic Biomarkers of PMDD

Recruitingn/aAges 18 Years - 50 YearsFemaleJohns Hopkins University
NCT06771583 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 mense

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Johns Hopkins Reproductive Mental Health Center
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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