[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537511":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":161,"collaborators":163,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":167,"sex":173,"minAge":174,"maxAge":29,"enrollmentInfo":175,"targetDuration":29,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":29,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"The George Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Esketamine group","ACTIVE_COMPARATOR","Dosing of esketamine intranasal spray will be guided by the Spravato® Product Information. This involves a starting dosage of 28 or 56 mg, with dose adjustment up to 84 mg as required to optimise response. Dose adjustments will be based on effectiveness and tolerability to the previous dose. The recommended treatment protocol is twice per week for 4 weeks, then weekly in weeks 5-8, then option of weekly-fortnightly \"maintenance\" treatment for responders. After week 8, patients may continue treatment as guided by the ketamine clinic psychiatrist.",[13],"Drug: Esketamine group",{"label":15,"type":10,"description":16,"interventionNames":17},"Racemic ketamine","Treatment administration will follow standard clinical practice in the recruiting clinic, with a recommendation to follow an evidence-based and established dose-optimising approach, given by injection, twice per week for 4 weeks, then the frequency of further treatments (week 5 - month 6) will be based on the clinical judgement of the ketamine clinic psychiatrist.\n\nDosing will be adjusted by the ketamine clinic psychiatrist, based on clinical response, safety and tolerability. The psychiatrist will review the patient before each treatment, over the first 4 weeks, to judge the dose level required.\n\nTypically, dosing will begin at the standard dose of 0.5 mg\u002Fkg and adjusted using an ascending dose titration schedule if the patient has not shown clinical response and if side effects are adequately tolerated.\n\n.",[18],"Drug: Racemic ketamine",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","The recommended dosing for Spravato is:\n\nWeeks 1-4:\n\nStarting Day 1 dose:\n\n\\\u003C 65 years: 56 mg\n\n≥ 65 years: 28 mg\n\nSubsequent doses:\n\n28 mg (≥ 65 years), 56 mg or 84 mg twice weekly\n\nWeeks 5-8:\n\n28 mg (≥ 65 years), 56 mg or 84 mg once weekly\n\nFrom Week 9:\n\n28 mg (≥ 65 years), 56 mg or 84 mg every 2 weeks or once weekly",[9],[25],"Spravato®",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"Typically, dosing will begin at the standard dose of 0.5 mg\u002Fkg and adjusted as needed using an ascending dose titration schedule:\n\n1. 0.5 mg\u002Fkg\n2. 0.6 mg\u002Fkg\n3. 0.75 mg\u002Fkg\n4. 0.9 mg\u002Fkg\n5. Further increments by 0.1-0.2 mg\u002Fkg, up to max 1.5 mg\u002Fkg",[15],null,[31],{"name":32,"affiliation":33,"role":34},"Colleen Loo","The University of New South Wales","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":29,"email":40},"Abigail Hansen","CONTACT","80524300","Trek@georgeinstitute.org.au",{"name":42,"role":38,"phone":39,"phoneExt":29,"email":40},"Fay Wang",[44,64,79,94,112,129,145],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Royal Prince Alfred Hospital","RECRUITING","Camperdown","New South Wales","2050","Australia","AU",{"type":53,"coordinates":54},"Point",[55,56],151.17642,-33.88965,{"lat":56,"lon":55},[59,62],{"name":60,"role":38,"phone":29,"phoneExt":29,"email":61},"Nicollette Thornton","SLHD-RPA-KetamineClinic@health.nsw.gov.au",{"name":63,"role":34,"phone":29,"phoneExt":29,"email":29},"Nicholas Glozier",{"facility":65,"status":46,"city":66,"state":48,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Black Dog Institute","Randwick","2031",{"type":53,"coordinates":69},[70,71],151.24895,-33.91439,{"lat":71,"lon":70},[74,77],{"name":75,"role":38,"phone":29,"phoneExt":29,"email":76},"Angelo Alonzo","depressionclinic@blackdog.org.au",{"name":78,"role":34,"phone":29,"phoneExt":29,"email":29},"Adam Bayes",{"facility":80,"status":46,"city":81,"state":48,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Ramsay Clinic Northside","St Leonards","2065",{"type":53,"coordinates":84},[85,86],151.19836,-33.82344,{"lat":86,"lon":85},[89,93],{"name":90,"role":38,"phone":91,"phoneExt":29,"email":92},"Yalda Pishyar","+61 2 8425 3022","neuroinfo.nsc@ramsayhealth.com.au",{"name":32,"role":34,"phone":29,"phoneExt":29,"email":29},{"facility":95,"status":46,"city":96,"state":48,"zip":97,"country":50,"countryCode":51,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Ramsay Clinic Lakeside","Warners Bay","2282",{"type":53,"coordinates":99},[100,101],151.65268,-32.97251,{"lat":101,"lon":100},[104,108,110],{"name":105,"role":38,"phone":106,"phoneExt":29,"email":107},"Hollie Ritchie","+61 3 4947 5169","ClinicalTrialsUnit.WBP@ramsayhealth.com.au",{"name":109,"role":38,"phone":29,"phoneExt":29,"email":107},"Natasha Cairns",{"name":111,"role":34,"phone":29,"phoneExt":29,"email":29},"Michael Bull",{"facility":113,"status":46,"city":114,"state":115,"zip":116,"country":50,"countryCode":51,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Gold Coast University Hospital","Southport","Queensland","4215",{"type":53,"coordinates":118},[119,120],153.39796,-27.96724,{"lat":120,"lon":119},[123,127],{"name":124,"role":38,"phone":125,"phoneExt":29,"email":126},"Laura McCosker","+61 417207575","laura.mccosker2@health.qld.gov.au",{"name":128,"role":34,"phone":29,"phoneExt":29,"email":29},"Shanthi Sarma",{"facility":130,"status":46,"city":131,"state":132,"zip":133,"country":50,"countryCode":51,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Ramsay Clinic Albert Road","Melbourne","Victoria","3004",{"type":53,"coordinates":135},[136,137],144.96332,-37.814,{"lat":137,"lon":136},[140,143],{"name":141,"role":38,"phone":29,"phoneExt":29,"email":142},"Melanie Hurley","research.arc@ramsayhealth.com.au",{"name":144,"role":34,"phone":29,"phoneExt":29,"email":29},"Malcolm Hopwood",{"facility":146,"status":46,"city":147,"state":132,"zip":148,"country":50,"countryCode":51,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Royal Melbourne Hospital","Parkville","3052",{"type":53,"coordinates":150},[151,152],144.95,-37.78333,{"lat":152,"lon":151},[155,159],{"name":156,"role":38,"phone":157,"phoneExt":29,"email":158},"Orli Schwartz, Study Coordinator, PHD","61-3-8344-0944","orli@unimelb.edu.au",{"name":160,"role":34,"phone":29,"phoneExt":29,"email":29},"Christopher Davey",{"type":162,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[164],{"name":33,"class":6},"100537511","phase-4-comparative-effectiveness-study-of-two-forms-of-ketamine-for-treatment-resistant-depression-100537511",false,"NCT06278779","Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression","Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial","TREK","Inclusion Criteria:\n\n* Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)\n* Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD\n* MADRS score of ≥20 at study baseline, assessed by certified study rater\n* Aged ≥18 years\n* Written informed consent for research study obtained\n\nExclusion Criteria:\n\n* Not able to give informed consent\n* Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments\n* Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study\n* Patients who require an interpreter\u002Ftranslator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales","ALL","18 Years",{"count":176,"type":177},162,"ESTIMATED","INTERVENTIONAL",[180],"PHASE4","The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:\n\n* How the two formulations compare in terms of their effectiveness in treating TRD.\n* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.\n\nParticipants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.",[183],"Treatment Resistant Depression","2026-05-27",{"date":186,"type":187},"2026-05-29","ACTUAL",{"date":189,"type":187},"2024-06-03",{"date":191,"type":177},"2027-04",{"name":5,"class":6},7]