[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583055":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":43,"centralContacts":48,"locations":34,"responsibleParty":53,"collaborators":34,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":34,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":34,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":34},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8,16,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy voluntary group","ACTIVE_COMPARATOR","20 menstruating women with a regular menstrual cycle that lasts between 25 and 35 days, not using hormonal contraception and without a psychiatric and\u002For neurological diagnosis.",[13,14,15],"Other: Semi-structured interviews SCID","Other: Self-report questionnaires","Other: Momentary Ecological Assessment (EMA)",{"label":17,"type":18,"description":19,"interventionNames":20},"Autism female patients group","EXPERIMENTAL","20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.",[13,14,15],{"label":22,"type":18,"description":23,"interventionNames":24},"Group of female patients with BPD","20 female patients with a diagnosis of BPD, according to DSM-5 criteria.",[13,14,15],{"label":26,"type":6,"description":27,"interventionNames":28},"Group of female patients with PMDD","20 patients with a diagnosis of PMDD, according to DSM-5 criteria",[13,14,15],[30,35,39],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Semi-structured interviews SCID","Structured Clinical Interview for DSM-5 Personality Disorder (SCID) :\n\nThe SCID is a 90-item semi-structured interview, covering all 10 categories of personality disorder as described in the DSM-5. Each item is rated on a three-point scale: \"absent\", \"subclinical level\" and \"present\".",[17,22,26,9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Self-report questionnaires","Participants will complete a battery of self-report questionnaires, assessing emotional dysregulation (including SRD, the primary endpoint), childhood adversity, anxiety, depression, and premenstrual symptoms.",[17,22,26,9],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Momentary Ecological Assessment (EMA)","A momentary ecological assessment protocol will be proposed between the inclusion visit and the end-of-protocol visit in order to evaluate emotional and symptomatic dynamics in a daily life context. For two menstrual cycles, subjects will be invited, via their smartphone, to make daily recordings (prompted by SMS) of their subjective emotional experiences (3 times\u002Fday).",[17,22,26,9],[44],{"name":45,"affiliation":46,"role":47},"Luisa WEINER, Professor","Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg","PRINCIPAL_INVESTIGATOR",[49],{"name":45,"role":50,"phone":51,"phoneExt":34,"email":52},"CONTACT","0388116511","luisa.weiner@chru-strasbourg.fr",{"type":54,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100583055","perimenstrual-symptoms-and-emotional-dysregulation-in-autism-100583055",false,"NCT06871345","Perimenstrual Symptoms and Emotional Dysregulation in Autism","Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic Individuals: Ecological, Subjective, and Cognitive Approach","MEDEA","Inclusion criteria:\n\nCommon Inclusion Criteria for Healthy Patients and Volunteers:\n\n* Female aged 18 to 45;\n* Woman with regular menstrual cycles (variations in duration, measured between the shortest menstrual cycle) and the longest cycle, remain strictly less than 7 days) between 25 and 35 days;\n* Woman without hormonal contraception (or NON-hormonal copper IUD) or who has stopped contraception for more than 3 months (and does not wish to take it again);\n* Woman with a smartphone with an internet connection;\n* Woman able to understand the objectives and risks of the research and to give informed, dated and signed consent;\n* Woman affiliated to a social protection health insurance scheme, beneficiary or beneficiary.\n\nPatient-specific inclusion criteria:\n\n* Specific inclusion criteria for female patients\n* Patient with a diagnosis of Autism Spectrum Disorder without intellectual disability (ASD), according to DSM-5 criteria OR\n* Patient with a diagnosis of BPD, according to DSM-5 criteria OR\n* Patient meeting the diagnostic criteria for PMDD with the SCID\n\nExclusion criteria:\n\nNon-inclusion criteria common to healthy patients and volunteers:\n\n* Taking hormonal treatment or synthetic steroids;\n* Woman using hormonal contraceptives (pill, patch, hormonal IUD, vaginal ring, implant, intramuscular injection);\n* Pregnancy or breastfeeding on the declaration of the person for less than 3 months;\n* Desire to become pregnant within 3 months of inclusion;\n* Endocrinopathies (in particular clinical signs of hyperandrogenism) or untreated gynaecological pathologies that may influence menstrual cycles and\u002For ovulation;\n* Participation in another study that may interfere with the study;\n* Inability to give the person informed information (person in an emergency or life-threatening situation);\n* Woman under judicial protection;\n* Woman under guardianship or curatorship;\n* Woman hospitalized for a period \\> 24 hours\n\nPatient-specific non-inclusion criteria:\n\n* Patient with a diagnosis of psychotic disorder;\n* Patient with a diagnosis of severe substance use disorder, i.e., presence of 6 or more symptoms;\n* Patient with a diagnosis of bipolar disorder type I or II or cyclothymia;\n* Patient with a diagnosis of co-occurring ASD and BPD;\n* Patient with an intellectual disability (IQ ≤ 70);\n* Patient with neurological comorbidity (e.g., acquired brain injury);\n* Patient on treatment that alters physiological response (heart rhythm, e.g., beta-blockers).\n\nNon-inclusion criteria specific to healthy volunteers:\n\n\\- Woman with a psychiatric, neurodevelopmental, or neurological history;",true,"FEMALE","18 Years","45 Years",{"count":68,"type":69},90,"ESTIMATED","INTERVENTIONAL",[72],"NA","Emotional dysregulation (ED) is defined by difficulties in modulating the experience and expression of emotions, which are characterized by particularly marked reactivity, intensity, and duration. To improve the understanding of ED, its consequences in autistic women, and to be able to offer them appropriate treatments, it seems crucial to investigate the links between ED, known adversities during childhood, and premenstrual dysphoric symptoms. This study aims to characterize the variability of ED throughout a menstrual cycle by measuring it in an ecological real-life context. The variability of ED will be compared to that of women with borderline personality disorder (BPD), women with premenstrual dysphoric disorder (PMDD), and women without a diagnosed disorder.",[75,76,77],"Autism Spectrum Disorder","Borderline Personality Disorder BPD","a Premenstrual Dysphoric Disorder (PMDD)","NOT_YET_RECRUITING","2026-05-11",{"date":81,"type":82},"2026-05-12","ACTUAL",{"date":84,"type":69},"2026-05-01",{"date":86,"type":69},"2029-07-01",{"name":5,"class":6}]