[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pmdd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pmdd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,55,84,114,137,164],{"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":11,"sex":18,"minAge":19,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":54},"100646710","transcutaneous-auricular-neurostimulation-tan-for-premenstrual-dysphoric-disorder-pmdd-and-perimenopause-100646710","NCT07688720","Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause","PMS\u002FPMDD Study:\n\nInclusion Criteria:\n\n* Assigned female at birth\n* Age 18 to 45\n* Naturally cycling\n* Regularly occurring menstrual cycle\n* Must identify as having PMS or PMDD\n* Reliable ability to complete online study surveys\n\nExclusion Criteria:\n\n* Using hormonal birth control\n* Pregnant or lactating\u002Fbreastfeeding\n* History of seizures\n* Implanted devices\n* Current or previous diagnosis of any heart conditions\n* Abnormal ear anatomy\n* Non-removable piercings on the ear\n* Recent ear infection\n* Taking SSRIs\n* Taking steroids\n* Taking hormone therapy\n* If the participant anticipates starting or stopping prescription medications during the study period\n* Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)\n* Participant has a history traumatic brain injury within the past 12 months\n* Must not have any other mental illness or mood disorder\n\nPerimenopause Study:\n\nInclusion Criteria:\n\n* Assigned female at birth.\n* Age 40 to 55\n* Must have newly variable menstrual cycles or report identifying as perimenopausal\n* Reliable ability to complete online study surveys\n\nExclusion Criteria:\n\n* Using hormonal birth control\n* Pregnant or lactating\u002Fbreastfeeding\n* History of seizures\n* Implanted devices\n* Current or previous diagnosis of any heart conditions\n* Abnormal ear anatomy\n* Non-removable piercings on the ear\n* Recent ear infection\n* Taking SSRIs\n* Taking steroids\n* Taking hormone therapy\n* If the participant anticipates starting or stopping prescription medications during the study period.\n* Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)\n* Participant has a history traumatic brain injury within the past 12 months\n* have a hysterectomy\n\nIn both studies we will confirm that participants are symptomatic shortly following enrollment.","55 Years",{"count":63,"type":23},20,"INTERVENTIONAL",[66],"NA","Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention, and following the intervention.",[69,28],"Perimenopause",[71,72,73,69,27],"Premenstrual Symptoms","Menopause","Women's health","RECRUITING","2026-06-30",{"date":77,"type":46},"2026-07-07",{"date":79,"type":23},"2026-06",{"date":81,"type":23},"2027-03",{"name":83,"class":53},"Texas Christian University",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":91,"enrollmentInfo":92,"targetDuration":94,"studyType":24,"phases":4,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"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":93,"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.",[28,30,97,98,99],"Premenstrual Syndrome-PMS","Premenstrual Syndrome","Menstrual Cycle",[32,101,34,35,36,37,102,103,40,33,104],"pms","epigenetics","dna methylation","women","2026-05-06",{"date":107,"type":46},"2026-05-07",{"date":109,"type":46},"2025-09-12",{"date":111,"type":23},"2031-02-15",{"name":113,"class":53},"Johns Hopkins University",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":28,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":18,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":64,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":54},"100635612","evaluating-the-impact-of-psychoeducation-and-sleep-informed-workshop-targeting-sleep-concerns-in-women-and-individuals-with-premenstrual-dysphoric-disorder-100635612","NCT07554950","Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder","Evaluating the Subjective and Objective Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Difficulties in Individuals With Premenstrual Dysphoric Disorder","Inclusion Criteria:\n\n1. Aged 16 and above\n2. positive screening for severe PMS and PMDD as per the Premenstrual Severity Screening Tool (PSST)\n3. experiencing sleep difficulties captured by a score of 12 or greater on the Insomnia Severity Index (ISI)\n4. reported regular menstrual cycle (average length of 25-35 days)\n5. not taking psychoactive medication or oral contraceptives or a) participants must be on a stable in dose and type for at least 8 weeks prior to the start of the study and b) medications remain stable throughout the study\n6. fluent in English, minimal grade 8 reading level to understand written materials\n7. individuals must have access to a smart phone or tablet with stable internet connection in order to complete study daily questionnaires\n\nExclusion Criteria:\n\n1. Severe cognitive disability that could impact the understanding of the clinical questionnaires\n2. a diagnosis of schizophrenia or any other primary psychotic disorder or current alcohol or substance use disorders\n3. presence of any unstable medical conditions","16 Years",{"count":123,"type":23},72,[66],"Premenstrual Dysphoric Disorder (PMDD) is a cyclical mood disorder characterized by emotional, cognitive, physical, and sleep-related symptoms that occur in the days leading up to menstruation and improve shortly after menstruation begins. Although medications are commonly used to treat PMDD, many individuals experience side effects, do not benefit from medication, or prefer non-medication-based approaches. Sleep difficulties are very common in individuals with PMDD and may contribute to mood symptoms, emotional regulation difficulties, and functional impairment. Psychological interventions that focus on sleep, such as sleep psychoeducation and cognitive-behavioural strategies for insomnia, are effective in other mood and anxiety disorders but have not been well studied in PMDD. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored for individuals with PMDD or severe premenstrual symptoms. Information collected in this study may help inform future research and may improve care for individuals with PMDD.",[127,28,128],"Sleep Disturbances","PMS","2026-04-21",{"date":131,"type":46},"2026-04-28",{"date":79,"type":23},{"date":134,"type":23},"2027-12",{"name":136,"class":53},"St. Joseph's Healthcare Hamilton",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":54},"100526102","stress-inflammation-and-neuroimaging-in-major-depressive-disorder-as-compared-to-premenstrual-dysphoric-disorder-100526102","NCT06130371","Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder","Inclusion Criteria:\n\n* Women,\n* age between 18 and 40 years (no menopausal women),\n* regular menstrual cycles (25-31 days),\n* normal body mass index (18-35 kg\u002Fm2),\n* German language fluency\n\nExclusion Criteria:\n\n* any neurological or mental disease (only for healthy participants)\n* hormonal, metabolic or chronical diseases\n* pregnancy\n* women who gave birth or were breastfeeding within the last year\n* women with any kind of steroid hormonal treatment\n* oral contraceptive treatment in the last three months\n* psychotropic treatment, only if regular\n* engagement in competitive sports\n* shift work","40 Years",{"count":145,"type":23},75,"Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women.\n\nStress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity.\n\nThere are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study.",[148,28],"MDD",[148,28,150,151,152,153,154],"Stress","Inflammation","Cytokines","fMRI","MIST","2026-03-31",{"date":157,"type":46},"2026-04-07",{"date":159,"type":46},"2024-01-04",{"date":161,"type":23},"2026-07",{"name":163,"class":53},"University Hospital Tuebingen",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":64,"phases":175,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":54},"100607495","microdosing-lsd-in-women-with-premenstrual-disorders-100607495","NCT07189299","Microdosing LSD in Women With Premenstrual Disorders","Role of the Serotonin 2A Receptor in Women With Premenstrual Disorders: a Randomized, Double-blind, Placebo-controlled Study (L4Her-Study)","L4Her","Inclusion crtieria:\n\n* Between 18-45 years.\n* Are menstruating and have cycles with a duration between 21 - 35 days.\n* Meet DSM-V criteria for PMDD or criteria for severe PMS with daily ratings over 2 cycles to confirm luteal symptoms.\n\n  1. For PMDD, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 5 Symptoms on the DRSP including 1 mood symptom during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase score must not be \\>2 on these same items.\n  2. For severe PMS, participants must have a minimal average luteal phase score of mild (≥3 on a 6-point scale) for at least 4 Symptoms on the DRSP including 1 mood symptom, during the 5 most symptomatic of the final 7 luteal phase days and the first 2 days of menses onset, and the average follicular phase core must not be \\>2 on these same items.\n* Have reported PMDD\u002FPMS symptoms for the majority of menstrual cycles (\\>9 of 12) during the year prior to screening.\n* Sufficient understanding of the German language\n* Sufficient understanding of the study procedures and risks associated with the study.\n* Participants must be willing to adhere to the study procedures and sign the consent form.\n* Willing not to drive or operate heavy machinery during the acute treatment phases of the study.\n* Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, and any illicit substances.\n* Willing to use effective contraceptive measures throughout study participation.\n\nExclusion Criteria:\n\n* Known hypersensitivity to LSD\n* Current treatment for PMS\u002FPMDD\n* Use of an oral hormonal contraceptive \\\u003C 6 months.\n* Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.\n* First degree relative with a psychotic disorder.\n* Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6).\n* Borderline personality disorder.\n* Current post-traumatic stress disorder.\n* Pregnant or breastfeeding\n* Planned pregnancy.\n* Current or recent history of significant suicide ideation or suicide behavior within the past 6 months.\n* Current substance use disorder (\\\u003C 12 months) other than tobacco smoking.\n* Other illness that excludes repeated LSD administration or requires interfering medication.\n* Participation in another clinical trial (currently or within the last 30 days)","45 Years",{"count":174,"type":23},150,[66],"The investigators aim to investigate the role of the serotonin 2A receptor in women with premenstrual disorders. This study uses a double-blind, randomized, controlled design with 3 arms: Intervention 1: 10 micg LSD for \\~10 days during the late luteal phase (for 3 cycles) Intervention 2: 10 micg LSD every other day for \\~10 days during the late luteal phase (for 3 cycles) Control intervention: Placebo for \\~10 days during the late luteal phase (for 3 cycles) Each participant will be treated in only one arm. The study employs a parallel design with three treatment arms and consists of a two-cycle observational phase followed by a three-cycle treatment phase.",[128,28],[179,180,181,182,183,184,185,186,187],"Hallucinogens","Serotonin Agents","LSD","Premenstrual disorders","Premenstrual syndrome","Psychotropic drugs","Microdose","Serotonin system","Psychedelics","2025-09-16",{"date":190,"type":46},"2025-09-23",{"date":192,"type":23},"2025-10-01",{"date":194,"type":23},"2030-01-01",{"name":196,"class":53},"Friederike Holze"]