[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Friederike Holze\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100607495",false,"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)","FEMALE","18 Years","45 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28],"PMS","PMDD",[30,31,32,33,34,35,36,37,38],"Hallucinogens","Serotonin Agents","LSD","Premenstrual disorders","Premenstrual syndrome","Psychotropic drugs","Microdose","Serotonin system","Psychedelics","NOT_YET_RECRUITING","2025-09-16",{"date":42,"type":43},"2025-09-23","ACTUAL",{"date":45,"type":21},"2025-10-01",{"date":47,"type":21},"2030-01-01",{"name":49,"class":50},"Friederike Holze","OTHER",""]