[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100652166","the-spark-pmdd-study-100652166",false,"NCT07771426","The SPARK-PMDD Study","Studying Psychological Changes And inflammatoRy marKers in Premenstrual Dysphoric Disorder (PMDD)","SPARK-PMDD","Inclusion Criteria:\n\nParticipants must:\n\n* Have been assigned female sex at birth (AFAB), with ovaries\n* Be aged between 18-42 years (inclusive)\n* Be able to provide written informed consent\n* Be premenopausal\n* Have regular menstrual cycles (24-35 days; 5-8 menstrual cycles within the previous 6 months)\n* Have a body mass index (BMI) between 18 and 30 kg\u002Fm².\n* Have access to a computer, tablet or smartphone with an internet connection.\n* Be registered with a UK General Practitioner (GP) and consent to the study team contacting their GP if clinically indicated.\n\nPMDD group only - Participants must additionally:\n\n• Meet DSM-5 diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD), confirmed through prospective symptom ratings and the study diagnostic assessment.\n\nHealthy control group only - Participants must additionally:\n\n* Have no current or previous diagnosis of PMDD.\n* Report no clinically significant premenstrual symptoms on prospective symptom ratings.\n* Have no lifetime psychiatric illness\n* Meet all other study eligibility criteria.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n* Have a lifetime history of a psychotic disorder (including schizophrenia, schizoaffective disorder or major depressive disorder with psychotic features) or bipolar disorder (past or present)\n* Meet criteria for any other current major psychiatric disorder that would interfere with study participation, as determined by the MINI International Neuropsychiatric Interview.\n* Have a history of drug or alcohol dependence within the previous 12 months.\n* Have a diagnosed intellectual disability, pervasive developmental disorder or significant neurological disorder (e.g. Alzheimer's disease, epilepsy or Parkinson's disease).\n* Are currently pregnant or breastfeeding, or are planning pregnancy during the study period.\n* Have an acute infection, autoimmune disorder, or regularly use anti-inflammatory or antibiotic medication that could influence immune biomarkers.\n* Have a current or previous gynaecological condition (e.g. endometriosis or polycystic ovary syndrome) or have undergone gynaecological surgery within the previous 12 months.\n* Have used hormonal contraception or other steroid hormone treatment within the previous 6 months (except emergency levonorgestrel contraception or temporary hormone treatment for oocyte cryopreservation that has not affected menstrual cycle regularity).\n* Have a significant medical condition that may affect study outcomes (e.g. cancer, inflammatory disease, liver disease, kidney disease or Crohn's disease).\n* Are currently participating in a Clinical Trial of an Investigational Medicinal Product (CTIMP). Eligibility following recent participation in a CTIMP will be considered on a case-by-case basis.\n* Are assessed as presenting an immediate or high risk of suicide requiring urgent clinical intervention. Suicidal ideation alone is not an exclusion criterion because it is recognised as a feature of PMDD; however, participants identified as being at significant risk will be excluded and referred to appropriate clinical services.",true,"FEMALE","18 Years","42 Years",{"count":22,"type":23},120,"ESTIMATED","OBSERVATIONAL","Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of \"hyperactivity\" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. This response is referred to as inflammation. This discovery has unveiled unique opportunities to identify new medications to help patients with this heightened inflammation who have also not been responding to their antidepressant medications.\n\nThis study aims to explore how inflammation in the body may be linked to symptoms of Premenstrual Dysphoric Disorder (PMDD) across the menstrual cycle, and how thoughts, emotions, and behaviours also may change throughout the cycle. We are recruiting two groups of people: People with a clinical or provisional (suspected) diagnosis of PMDD, and healthy controls who experience mild\u002Fno premenstrual changes.\n\nOver a two-month period, participants will complete daily psychological assessments across two menstrual cycles and will come into King's College Hospital (KCH) twice during one menstrual cycle to provide blood samples to measure their inflammation. By comparing these groups, we hope to gain a better understanding of the biological and psychological factors involved in PMDD, with the long-term goal of improving treatment options.",[27,28,29,30],"Premenstrual Dysphoric Disorder","PMDD","Premenstrual Dysphoric Disorder ( PMDD)","Premenstrual Dysphoric Disorder (PMDD)",[32,33,34,35,36,37,38,39,40,41],"menstrual cycle","pmdd","luteal phase","womens health","reproductive health","reproductive mental health","inflammation","stress","premenstrual","female","NOT_YET_RECRUITING","2026-08-14",{"date":45,"type":46},"2026-08-18","ACTUAL",{"date":48,"type":23},"2027-01-01",{"date":50,"type":23},"2029-10-01",{"name":52,"class":53},"King's College London","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":62,"enrollmentInfo":63,"targetDuration":65,"studyType":24,"phases":4,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":54},"100575384","identification-and-validation-of-epigenetic-biomarkers-of-pmdd-100575384","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.","50 Years",{"count":64,"type":23},500,"3 Months","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.",[28,30,68,69,70],"Premenstrual Syndrome-PMS","Premenstrual Syndrome","Menstrual Cycle",[32,72,34,35,36,37,73,74,40,33,75],"pms","epigenetics","dna methylation","women","RECRUITING","2026-05-06",{"date":79,"type":46},"2026-05-07",{"date":81,"type":46},"2025-09-12",{"date":83,"type":23},"2031-02-15",{"name":85,"class":53},"Johns Hopkins University",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":62,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"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":94,"type":23},288,"INTERVENTIONAL",[97],"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.",[30],[33,101,72,102,103,104,105,106,107,75,108,109,34,110,111,35,112,32,113,114,115,116,117,73],"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":79,"type":46},{"date":120,"type":46},"2025-05-14",{"date":122,"type":23},"2029-07-01",{"name":85,"class":53},2]