[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premenstrual-dysphoric-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premenstrual-dysphoric-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,100,129],{"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":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":66,"conditions":67,"keywords":74,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":54},"100645235","crest-samphire-guided-care-program-on-wellbeing-work-productivity-and-quality-of-life-100645235","NCT07679074","CREST: Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life","A 12-Week Prospective Cohort Study Evaluating the Efficacy of the Samphire Guided Care Program on Wellbeing, Work Productivity, and Quality of Life in Individuals With Menstrual and Pelvic Health Conditions","CREST","Inclusion Criteria:\n\n* Self-identified female, aged 18-65 years at the time of enrollment\n* Basic English literacy\n* Able and willing to provide informed consent electronically\n* Residing in the United States\n* Reporting mood or cognitive symptoms associated with menstruation, perimenopause, or menopause (must endorse a minimum of three of the following: irritability, emotional dysregulation, brain fog, fatigue, reduced concentration, sleep disruption, or low mood)\n* Symptoms present for at least 3 months and sufficiently severe to interfere with daily functioning, work performance, quality of life, or interpersonal relationships\n* Currently in full-time employment with medical benefits as part of compensation package\n* Access to a smartphone with internet access compatible with the Samphire mobile application\n* Able to safely operate the study device in the home environment\n* Willing to complete baseline, mid-program, and end-of-program questionnaires and engage with the 12-week guided care program\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding, or actively planning pregnancy during the study period\n* History of epilepsy or seizure disorder\n* Severe or unstable neurological disease that, in the opinion of the study team, may increase risk or interfere with participation\n* Implanted electronic or metal devices in the head, neck, or brain region contraindicated for tDCS use\n* Active scalp lesions, open wounds, or dermatologic conditions at electrode sites that may interfere with safe device use\n* Current diagnosis of schizophrenia, bipolar disorder, or other severe psychiatric condition that would make participation inappropriate, as determined by screening\n* Active suicidal ideation, recent suicidal behavior, or clinically significant self-injurious behavior, as determined by participant self-report during screening\n* Inability to provide informed consent or safely use the device in the home environment\n* Current participation in another interventional neurotechnology or drug study","65 Years",{"count":65,"type":23},50,"This study evaluates the feasibility and efficacy of the Samphire Guided Care (SGC) program\n\n* a 12-week structured digital health program combining clinician-led onboarding, at-home neuromodulation using the Lutea tDCS device, neuromodulation coach support, and app-based symptom tracking - on work productivity, employee wellbeing, and quality of life in individuals experiencing mood and cognitive symptoms associated with menstruation, perimenopause, or menopause.",[68,27,69,70,71,72,73],"Premenstrual Syndrome","Dysmenorrhea","Endometriosis","Perimenopause","Menopause","Pelvic Pain",[75,76,77,78,79,80,28,81,82,83,84,85,86,87,88],"tDCS","neuromodulation","hormonal health","menstrual symptoms","perimenopause","menopause","PMS","work productivity","brain fog","mood","cognitive function","digital health","decentralized clinical trial","guided care","RECRUITING","2026-06-25",{"date":92,"type":46},"2026-07-01",{"date":94,"type":46},"2026-06-01",{"date":96,"type":23},"2027-03-01",{"name":98,"class":99},"Samphire Group, Inc.","INDUSTRY",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":54},"100554211","emotion-regulation-based-internet-delivered-cognitive-behavioural-therapy-for-premenstrual-dysphoric-disorder-100554211","NCT06496139","Emotion Regulation-based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder","Emotion Regulation Based Internet-delivered Cognitive Behavioural Therapy for Premenstrual Dysphoric Disorder: A Randomised Controlled Trial","Premensis-s","Inclusion Criteria:\n\n1. PMDD diagnosis according to DSM-5\n2. Menstrual cycle length between 23-34 days, i.e., 5-8 cycles in the last six months\n3. Sufficient proficiency in Swedish to comprehend the treatment materials\n4. Access to computer\u002Ftablet\u002Fmobile phone with internet connection\n\nExclusion Criteria:\n\n1. Breastfeeding or pregnancy during the previous three months\n2. Initiation of or change in treatment with antidepressants, benzodiazepines, contraceptives, or hormones during the last three months\n3. Current or history of a gynaecological disease (e.g., endometriosis, polycystic ovary syndrome) that may confound the results\n4. Ongoing or previous psychological treatment for premenstrual disorders\n5. Severe mental disorders that may interfere with the person's ability to complete the treatment or complicate the interpretation of results, e.g., psychosis, bipolar disorder, severe eating disorder, or severe depression\n6. Elevated suicide risk (e.g., recurrent active suicidal ideation, current suicide plans, previous suicide attempts).","45 Years",{"count":110,"type":23},164,"INTERVENTIONAL",[113],"NA","Premenstrual dysphoric disorder (PMDD) is a debilitating cyclic mental disorder affecting about 2-5% of women of reproductive age. PMDD is characterised by recurring emotional, behavioural, cognitive, and somatic symptoms that arise during the luteal (premenstrual) phase of the menstrual cycle and remit shortly after the onset of menses. Although pharmacological interventions are available, many women experience residual symptoms, discontinue treatment or refrain from them because of side effects. Therefore, non-pharmacological treatment options are needed.\n\nPreliminary evidence suggests that internet-delivered cognitive behavioural therapy (ICBT) is a promising candidate, but further research is warranted. Also, there is room for treatment improvement. Specifically, it has been suggested that components targeting emotional and interpersonal dysregulation should be incorporated into CBT for PMDD. The current study aims to assess the effects of an ICBT intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness in a randomised controlled trial (RCT).",[27],[117,118,119],"Internet-delivered cognitive behavioural therapy","Emotion regulation","Premenstrual dysphoric disorder","2025-07-28",{"date":122,"type":46},"2025-07-31",{"date":124,"type":46},"2025-07-14",{"date":126,"type":23},"2028-07",{"name":128,"class":53},"Uppsala University",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":136,"targetDuration":4,"studyType":111,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100565915","pilot-study-of-the-thriving-with-pmds-program-100565915","NCT06648382","Pilot Study of the 'Thriving With PMDs' Program","Pilot Test of a Self-Directed Psychotherapy Program for Premenstrual Disorders","Inclusion Criteria:\n\n* Ages 18-42\n* Either meeting diagnostic criteria for premenstrual dysphoric disorder (to be confirmed by researchers through daily symptom ratings for two menstrual cycles) or major depressive disorder with perimenstrual exacerbation (i.e. at least a 30% increase in 4 symptoms in the perimenstrual phase)\n\nExclusion Criteria:\n\n* Taking oral contraceptives\n* Currently in psychotherapy",{"count":65,"type":23},[113],"This study is testing a self-help mental health program that was designed to help people cope with the challenges of living with a premenstrual disorder. Individuals with a premenstrual disorder - either premenstrual dysphoric disorder or premenstrual exacerbation of depression - will track their daily symptoms for two menstrual cycles before they complete the program, throughout the two-cycle program, and for an additional two cycles after accessing the program. This will allow the research team to compare their symptoms before and after accessing the program.",[140,27],"Premenstrual Disorder",[142,143,119],"Psychotherapy","Premenstrual disorder","2025-04-03",{"date":146,"type":46},"2025-04-06",{"date":148,"type":46},"2024-10-15",{"date":150,"type":23},"2025-10",{"name":152,"class":53},"University of Regina",2]