[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premenstrual-dysphoric-disorder-pmdd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premenstrual-dysphoric-disorder-pmdd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"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":21,"type":22},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.",[27,28,29,30,31],"PMDD","Premenstrual Dysphoric Disorder (PMDD)","Premenstrual Syndrome-PMS","Premenstrual Syndrome","Menstrual Cycle",[33,34,35,36,37,38,39,40,41,42,43],"menstrual cycle","pms","luteal phase","womens health","reproductive health","reproductive mental health","epigenetics","dna methylation","premenstrual","pmdd","women","RECRUITING","2026-05-06",{"date":47,"type":48},"2026-05-07","ACTUAL",{"date":50,"type":48},"2025-09-12",{"date":52,"type":22},"2031-02-15",{"name":54,"class":55},"Johns Hopkins University","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":5},"100570234","phase-4-allopregnanolone-and-dynamic-gaba-a-receptor-plasticity-in-selective-serotonin-reuptake-inhibitor-responsive-premenstrual-dysphoric-disorder-100570234","NCT06704594","Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder","BLOOM","Inclusion Criteria:\n\n* female sex,\n* fluent in the English language\n* regular menstrual cycles (24-35 days)\n* age 18-50 years old\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 6 months\n* lifetime history of psychotic disorder including schizophrenia\n* schizoaffective disorder, major depression with psychotic features\n* history of psychiatric disorder other than PMDD in past year\n* active suicidal ideation with plan or attempt in past 6 months\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\n* History of arrythmias, severe liver impairment, history of seizure disorder\n* If currently taking the following meds: methylene blue, linezolid\n* Other prohibited concomitant meds are Monoamine oxidase inhibitors (MAOIs), pimozide, and disulfiram",{"count":65,"type":22},288,"INTERVENTIONAL",[68],"PHASE4","Premenstrual dysphoric disorder (PMDD) is a severe affective disorder impacting millions of women worldwide, thought to be due to altered sensitivity to hormone fluctuations across the menstrual cycle. Neuroactive steroid hormones (NAS) and the gamma-aminobutyric acid (GABA)-A receptor (GABAAR) are thought to play a role in PMDD. This research will assess the blood levels of GABAergic NAS, expression of associated enzymes, and expression of GABAAR subunits across the premenstrual (luteal) phase of the menstrual cycle in healthy controls and individuals with PMDD. Within the PMDD group, the investigators will assess how these measures are affected by a low-dose antidepressant medication versus placebo. The results will provide a comprehensive view of the changes in these systems across the menstrual cycle and will add to the investigator's understanding of the mechanisms that underlie PMDD, as well as therapeutic mechanisms of PMDD treatment.",[28],[42,72,34,73,74,75,76,77,78,43,79,80,35,81,82,36,83,33,84,85,86,87,88,39],"premenstrual dysphoric disorder","premenstrual symptoms","premenstrual syndrome","blood draw","sertraline","ssri","mood symptoms","women with pms","women with pmdd","follicular phase","womens reproductive mental health","womens reproductive health","menses","periods","allopregnanolone","neuroactive steroids","inflammatory markers",{"date":47,"type":48},{"date":91,"type":48},"2025-05-14",{"date":93,"type":22},"2029-07-01",{"name":54,"class":55}]