[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"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":4,"eligibilityCriteria":60,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":61,"enrollmentInfo":62,"targetDuration":64,"studyType":24,"phases":4,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":54},"100646706","to-establish-whether-individuals-with-premenstrual-dysphoric-disorder-pmdd-demonstrate-a-different-luteal-phase-sex-hormone-profile-and-ratio-compared-with-asymptomatic-controls-100646706","NCT07686718","To Establish Whether Individuals With Premenstrual Dysphoric Disorder (PMDD) Demonstrate a Different Luteal-phase Sex Hormone Profile and Ratio Compared With Asymptomatic Controls.","Inclusion criteria\n\n* Aged 18-45 years old (adults but less than the typical perimenopausal age so there is not added bias\u002Fvariable)\n* Regular menstrual cycles (21-35 days for the last 3 months)\n* Willing and able to complete a questionnaire (no new clinical diagnosis given)\n* Use home urine LH test strips to detect ovulation\n* Attend a single in person on site in Lancaster mid luteal blood test sample appointment (approx 7 days post LH surge)\n* Provide written informed consent\n* Have sufficient English language skills to understand the patient information\n* Be either in Group 1 or group 2 Group 1 (PMDD group ie case group) - self reported prior diagnosis of PMDD made by a healthcare professional (GP, psychiatrist, gynaecologist) Group 2 (Control group ie comparison group) - no prior diagnosis of PMDD made by a healthcare professional and no history of clinically significant premenstrual mood symptoms on screening\n\nExclusion criteria\n\n* Current use or use in the last 3 months of hormonal contraception such as the combined oral contraceptive pill, the progestogen only pill, the implant, the injection, hormonal coil (Mirena, Kyleena) or patch\u002Fring.\n* Current use or use in the last 3 months of any hormone replacement therapy (e.g. combined oestrogen and progesterone, oestrogen and Mirena coil combination, oestrogen alone if had a hysterectomy, or progesterone alone) or GnRH analogues use\n* On a selective serotonin reuptake inhibitor (SSRI) with a recent initiation or dose change within the last 3 months\n* Pregnant, breastfeeding or within 3 months post partum\n* Irregular menstrual cycles (outside the 21-35 day window)\n* Surgical menopause\n* Premature ovarian insufficiency\n* Other endocrine disorders e.g. uncontrolled thyroid disease, high prolactin, cushing's syndrome, polycystic ovarian syndrome)\n* Regular systemic steroid use or use of other medications known to affect sex hormone within the last 3 months\n* Severe mental health issues that impair consent or participation\n* Needle phobic so that venepuncture is intolerable\n* The use of the emergency contraceptive pill either 3 months prior to the study or during the study.","45 Years",{"count":63,"type":23},50,"6 Months","The aim of this project is to compare the ovarian hormone levels 7 days after ovulation and progesterone:oestradiol ratios between PMDD individuals and a control cohort (case control study).",[29],[28,68,69,70,71],"premenstrual dysphoric disorder","oestrogen","progesterone","ratios","RECRUITING","2026-06-29",{"date":75,"type":46},"2026-07-07",{"date":77,"type":46},"2026-05-05",{"date":79,"type":23},"2027-08-01",{"name":81,"class":53},"Lancaster University"]