[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575384":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":28,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":69,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Control",null,"Eligible participants that pass inclusion and exclusion criteria who do not have premenstrual mood symptoms.",{"label":13,"type":10,"description":14,"interventionNames":10},"Premenstrual Dysphoric Disorder (PMDD)","Eligible participants that pass inclusion and exclusion criteria who do have premenstrual mood symptoms. Symptoms must be severe enough to meet PMDD criteria.",[16],{"name":17,"affiliation":5,"role":18},"Liisa Hantsoo, Ph.D.","PRINCIPAL_INVESTIGATOR",[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Victoria Seo, B.S.","CONTACT","302-464-8320‬","vseo1@jh.edu",{"name":26,"role":22,"phone":10,"phoneExt":10,"email":27},"Victoria Paone, B.S.","vpaone1@jh.edu",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Johns Hopkins Reproductive Mental Health Center","RECRUITING","Baltimore","Maryland","21205","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-76.61219,39.29038,{"lat":41,"lon":40},[44,47,48],{"name":17,"role":22,"phone":45,"phoneExt":10,"email":46},"215-435-3171","lhantso1@jhmi.edu",{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},{"name":17,"role":18,"phone":10,"phoneExt":10,"email":10},{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[52],{"name":53,"class":54},"National Institute of Mental Health (NIMH)","NIH","100575384","identification-and-validation-of-epigenetic-biomarkers-of-pmdd-100575384",false,"NCT06771583","Identification and Validation of Epigenetic Biomarkers of PMDD","BIO","Inclusion Criteria:\n\n* female sex\n* regular menstrual cycles (24-35 days)\n* age 18-50 years\n* ability to give written informed consent\n\nExclusion Criteria:\n\n* psychiatric medication use in the past 2 months;\n* substance use disorder in the past 2 months (per MINI);\n* lifetime history of psychotic disorder including schizophrenia, schizoaffective disorder, major depression with psychotic features (per MINI);\n* history of psychiatric disorder other than PMDD in past year (per MINI);\n* active suicidal ideation with plan or attempt in past 6 months (per MINI);\n* steroid hormone or hormonal contraceptive use (except levonorgestrel as emergency contraceptive) in past 2 months;\n* pregnancy in past 6 months;\n* history of brain injury;\n* current or history of endocrine disorder including uncontrolled diabetes or thyroid disease;\n* BMI\\>40.",true,"FEMALE","18 Years","50 Years",{"count":67,"type":68},500,"ESTIMATED","3 Months","OBSERVATIONAL","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\u002Fpremenstrual dysphoric disorder (PMS\u002FPMDD). 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\u002FPMDD.",[73,13,74,75,76],"PMDD","Premenstrual Syndrome-PMS","Premenstrual Syndrome","Menstrual Cycle",[78,79,80,81,82,83,84,85,86,87,88],"menstrual cycle","pms","luteal phase","womens health","reproductive health","reproductive mental health","epigenetics","dna methylation","premenstrual","pmdd","women","2026-05-06",{"date":91,"type":92},"2026-05-07","ACTUAL",{"date":94,"type":92},"2025-09-12",{"date":96,"type":68},"2031-02-15",{"name":5,"class":6},1]