[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,57,84,111],{"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":62,"acronym":27,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":56},"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":66,"type":22},72,"INTERVENTIONAL",[69],"NA","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.",[72,27,73],"Sleep Disturbances","PMS","NOT_YET_RECRUITING","2026-04-21",{"date":77,"type":48},"2026-04-28",{"date":79,"type":22},"2026-06",{"date":81,"type":22},"2027-12",{"name":83,"class":55},"St. Joseph's Healthcare Hamilton",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":56},"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":92,"type":22},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.",[95,27],"MDD",[95,27,97,98,99,100,101],"Stress","Inflammation","Cytokines","fMRI","MIST","2026-03-31",{"date":104,"type":48},"2026-04-07",{"date":106,"type":48},"2024-01-04",{"date":108,"type":22},"2026-07",{"name":110,"class":55},"University Hospital Tuebingen",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":67,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":56},"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":121,"type":22},150,[69],"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.",[73,27],[126,127,128,129,130,131,132,133,134],"Hallucinogens","Serotonin Agents","LSD","Premenstrual disorders","Premenstrual syndrome","Psychotropic drugs","Microdose","Serotonin system","Psychedelics","2025-09-16",{"date":137,"type":48},"2025-09-23",{"date":139,"type":22},"2025-10-01",{"date":141,"type":22},"2030-01-01",{"name":143,"class":55},"Friederike Holze"]