[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573925":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":63,"collaborators":66,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":11,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Copenhagen","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Sublingual dexmedetomidine","EXPERIMENTAL",null,[13],"Drug: Sublingual Dexmedetomidine",{"label":15,"type":10,"description":11,"interventionNames":16},"Buccal midazolam",[17],"Drug: Buccal midazolam",{"label":19,"type":20,"description":11,"interventionNames":21},"Oral lorazepam","ACTIVE_COMPARATOR",[22],"Drug: Oral lorazepam",[24,29,32],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","Sublingual Dexmedetomidine","Sublingual dexmedetomidine 180 mcg, possible second dose 90 mcg after 2 hrs",[9],{"type":25,"name":15,"description":30,"armGroupLabels":31,"otherNames":11},"Buccal midazolam 10 mg, possible second dose 10 mg after 2 hrs",[15],{"type":25,"name":19,"description":33,"armGroupLabels":34,"otherNames":11},"Oral lorazepam 4 mg, possible second dose 4 mg after 2 hrs",[19],[36],{"name":37,"affiliation":38,"role":39},"Lone Baandrup, MD, DMSc","Mental Health Center Copenhagen","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":11,"email":44},"CONTACT","00 45 91165903","lone.baandrup@regionh.dk",{"name":46,"role":42,"phone":47,"phoneExt":11,"email":48},"Marie Vang Jensen, MD","0045 6199 7358","marie.said.vang.jensen@regionh.dk",[50],{"facility":51,"status":52,"city":53,"state":11,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":11,"geoPoint":11,"contacts":57},"Mental Health Center Copenhagen, Bispebjerg","RECRUITING","Copenhagen N","2400","Denmark","DK",[58,61],{"name":59,"role":42,"phone":60,"phoneExt":11,"email":44},"Lone Baandrup","0045 91165903",{"name":62,"role":42,"phone":11,"phoneExt":11,"email":11},"Marie Vang, MD",{"type":64,"investigatorFullName":59,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Head of Clinic, clinical associate research professor",[67,69],{"name":68,"class":6},"University Hospital Bispebjerg and Frederiksberg",{"name":70,"class":71},"Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark","UNKNOWN","100573925","phase-2-acute-agitation-in-emergency-psychiatry-100573925",false,"NCT06752616","Acute Agitation in Emergency Psychiatry","Advancing the Quality of Treatment and Care for Acute Agitation in Emergency Psychiatry","Inclusion Criteria:\n\n* 18-64 years\n* Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms\n* Total score of ≥14 on the PANSS Excited Component (PEC)\n* A score ≥4 on at least 1 of the 5 items of the PEC\n* Informed consent obtained prior to the occurrence of the emergency\n\nExclusion Criteria:\n\n* Involuntary psychiatric admission according to the Danish Mental Health Act\n* Female patients who are breastfeeding\n* Female patients aged \\\u003C50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives\n* Body weight \\\u003C50 kg\n* Extreme obesity defined as estimated BMI≥ 40 kg\u002Fm2\n* Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator)\n* The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator)\n* Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator)\n* Clinical suspicion of contraindications for one of the treatment arms\n* Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment\n* Known allergy to any of the study medications","ALL","18 Years","64 Years",{"count":83,"type":84},132,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE2","PHASE3","The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.",[91],"Agitation",[93],"Emergency psychiatry","2024-12-30",{"date":96,"type":97},"2025-01-01","ACTUAL",{"date":94,"type":97},{"date":100,"type":84},"2027-12",{"name":59,"class":6},1]