[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576777":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"3,4-methylenedioxymethamphetamine (MDMA) and Placebo","EXPERIMENTAL","In this arm, first MDMA is given and after a wash-out phase of at least 10 days, Placebo will be administered.",[13,14],"Drug: MDMA","Other: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo and 3,4-methylenedioxymethamphetamine (MDMA)","In this arm, first Placebo is given and after a wash-out phase of at least 10 days, MDMA will be administered.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","MDMA","MDMA will be administered in a single dose of 50 mg (2 capsules of 25 mg MDMA) or 25mg (1 capsule of 25 mg MDMA, 1 capsule containing only mannitol filler) and given at treatment visit.",[9,16],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Placebo will be prepared as identical gelatin capsules containing only mannitol filler and given at treatment visit.",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Mirjam Christ-Crain, Prof.","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+41 61 265 25 25","Mirjam.Christ-Crain@usb.ch",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University Hospital Basel","RECRUITING","Basel","4031","Switzerland","CH",{"type":48,"coordinates":49},"Point",[50,51],7.57327,47.55839,{"lat":51,"lon":50},[54,55],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100576777","plasma-oxytocin-changes-in-response-to-low-dose-mdma-vs-placebo-in-patients-with-arginine-vasopressin-deficiency-and-healthy-controls-100576777",false,"NCT06789705","Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls","Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency (Central Diabetes Insipidus) and Healthy Controls - the OxyMAX Study","OxyMAX","Inclusion criteria patients:\n\n1\\. Adult patients with confirmed diagnosis of Arginine Vasopressin deficiency (central diabetes insipidus)2 or with only anterior pituitary deficiency\n\nInclusion criteria healthy controls:\n\n1. Adult healthy controls\n2. Matched for age, sex, Body mass index, and oestrogen replacement\u002Fmenopause\u002Fhormonal contraceptives to patients\n3. No medication, except hormonal contraception\n\nExclusion Criteria:\n\n1. Participation in a trial with investigational drugs within 30 days\n2. Illicit substance use (except for cannabis) more than 10 times in lifetime or any time within the previous two months\n3. Consumption of alcoholic beverages \\>15 drinks\u002Fweek\n4. Tobacco smoking \\>10 cigarettes\u002Fday\n5. Cardiovascular disease (coronary artery disease, heart failure Left ventricular ejection fraction \\\u003C40%, stroke in the last 3 months, atrial fibrillation\u002Fflatter, Wolff-Parkinson-White-Syndrome)\n6. Uncontrolled arterial hypertension (\\>140\u002F90 mmHg) or hypotension (\\\u003C85mmHg)\n7. Current or previous major psychiatric disorder (e.g., major depression, schizophrenia spectrum disorder)\n8. Psychotic disorder in first-degree relatives\n9. Regular intake of selective serotonin reuptake inhibitors or Monoamine oxidase inhibitors\n10. Pregnancy and breastfeeding\n11. Diagnosed Chronic Kidney Disease \\> grade III (glomerular filtration rate \\\u003C 30ml\u002Fmin)\n12. Diagnosed liver cirrhosis or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) levels 2.5 times above the normal range",true,"ALL","18 Years",{"count":70,"type":71},24,"ESTIMATED","INTERVENTIONAL",[74],"NA","The investigator hypothesize that low-dose MDMA (3,4-methylenedioxymethamphetamine) will produce a sufficiently strong oxytocin stimulation in healthy controls and no relevant increase in patients. This study will confirm previously published data and provide important safety data with low-dose MDMA stimulation testing.",[77],"Central Diabetes Insipidus",[22,79,80],"oxytocin","arginin vasopressin","2025-02-18",{"date":83,"type":84},"2025-02-19","ACTUAL",{"date":86,"type":84},"2025-01-27",{"date":88,"type":71},"2026-12",{"name":5,"class":6},1]