protocolSection identificationModule nctId: NCT06278779, orgStudyIdInfo id: X23-0311, briefTitle: Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression, acronym: TREK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: The George Institute, class: OTHER, collaborators name: The University of New South Wales, descriptionModule briefSummary: 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:* How the two formulations compare in terms of their effectiveness in treating TRD.* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.Participants 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., conditionsModule conditions: Treatment Resistant Depression, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, prospective, parallel group, comparative effectiveness trial., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Primary outcome raters will be blinded to treatment allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Esketamine group, interventions name: Racemic ketamine, outcomesModule primaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS) score, secondaryOutcomes measure: Response - Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Remission - Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: DASS-21, secondaryOutcomes measure: Clinical Global Impression-Improvement (CGI-I), secondaryOutcomes measure: Clinical Global Impression-Severity (CGI-S), secondaryOutcomes measure: Columbia Suicide Severity Rating Scale (C-SSRS), secondaryOutcomes measure: Speed of response - Clinical Global Impression-Improvement (CGI-I), secondaryOutcomes measure: Psychotomimetic symptoms, secondaryOutcomes measure: Suicide attempts or gestures, secondaryOutcomes measure: Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS), secondaryOutcomes measure: Cognitive Failure Questionnaire scores (CFQ), secondaryOutcomes measure: Ketamine liking/craving score, secondaryOutcomes measure: Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET), secondaryOutcomes measure: Acceptability Questionnaire, secondaryOutcomes measure: All-cause dropouts, secondaryOutcomes measure: Recovering Quality of Life Questionnaire (REQOL-10), secondaryOutcomes measure: WHO Disability Assessment Scale (WHODAS-12), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Assessment of Quality of Life Questionnaire (AQoL-8D), secondaryOutcomes measure: Resource Use Questionnaire (RUQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Prince Alfred Hospital, city: Camperdown, state: New South Wales, zip: 2050, country: Australia, contacts name: Hadley Lindsay, role: CONTACT, email: SLHD-RPA-KetamineClinic@health.nsw.gov.au, contacts name: Nicholas Glozier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.88965, lon: 151.17642, locations facility: Black Dog Institute, city: Randwick, state: New South Wales, zip: 2031, country: Australia, contacts name: Stella Antoniou, role: CONTACT, email: depressionclinic@blackdog.org.au, contacts name: Adam Bayes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.91439, lon: 151.24895, locations facility: Ramsay Clinic Northside, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: Mayra Ouriques, role: CONTACT, email: neuroinfo.nsc@ramsayhealth.com.au, contacts name: Colleen Loo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -33.82344, lon: 151.19836, locations facility: Ramsay Clinic Lakeside, city: Warners Bay, state: New South Wales, zip: 2282, country: Australia, contacts name: Sally Sally Wilkinson, role: CONTACT, email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au, contacts name: Natasha Cairns, role: CONTACT, email: ClinicalTrialsUnit.WBP@ramsayhealth.com.au, contacts name: Michael Bull, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.97251, lon: 151.65268, locations facility: Gold Coast University Hospital, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: Catherine Donald, role: CONTACT, email: specialistmooddisorderclinic@health.qld.gov.au, contacts name: Shanthi Sarma, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.96724, lon: 153.39796, locations facility: Ramsay Clinic Albert Road, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Melanie Hurley, role: CONTACT, email: research.arc@ramsayhealth.com.au, contacts name: Malcolm Hopwood, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.814, lon: 144.96332, hasResults: False