[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524057":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":31,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":37,"whyStopped":31,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Royal North Shore Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Participants with Major Depressive Disorder","Intranasal esketamine to be self-administered by participants under direct supervision of a healthcare professional. First initial dose is 56mg and subsequent doses will be 56mg or 84mg. Esketamine will be administered twice weekly for weeks 1-4, once weekly for weeks 5-8, and once weekly\u002Fonce fortnightly\u002Fonce monthly as clinically indicated for weeks 9-25. After each treatment phase, participants will be re-assessed through a comprehensive battery of assessments and dose adjustments will be performed by the study psychiatrist base on tolerability, treatment response, and ongoing consent.",[12],"Drug: Esketamine Nasal Spray [Spravato]",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Esketamine Nasal Spray [Spravato]","This is an uncontrolled, single arm, naturalistic study. There will be three treatment phases: Phase 1 - Acute treatment phase (weeks 1-4); Phase 2 - Maintenance treatment phase (weeks 5-8); Phase 3 - Continuation treatment phase (Weeks 9-25). Phase 1 is the critical component of our study as it determines our primary outcomes.",[9],[20],"Spravato",[22],{"name":23,"affiliation":24,"role":25},"Gin Malhi","Royal North Shore Hospital, University of Sydney","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Erica Bell","CONTACT","02 9462 9905",null,"NSLHD-researchpoet@health.nsw.gov.au",{"name":34,"role":29,"phone":31,"phoneExt":31,"email":32},"Yan Yau Wong",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","St Leonards","New South Wales","2065","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],151.19836,-33.82344,{"lat":47,"lon":46},[50,51],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":31,"phoneExt":31,"email":32},{"type":25,"investigatorFullName":23,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Professor",[55],{"name":56,"class":57},"Janssen-Cilag Pty Ltd","INDUSTRY","100524057","phase-4-positioning-of-esketamine-treatment-in-the-real-world-management-of-depression-100524057",false,"NCT06103760","Positioning of Esketamine Treatment in the Real-world Management of Depression","PoET","Inclusion Criteria:\n\n1. Adults aged 18-65 years old\n2. Diagnosis of Major Depressive Disorder (MDD)\n3. Currently depressed\n4. Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)\n5. Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment\n6. Able to understand and provide informed consent\n\nExclusion Criteria:\n\n1. Concurrent diagnoses:\n\n   * Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia\n   * Participants who are unable to understand the study and therefore unable to provide informed consent\n2. Pregnancy:\n\n   * Participants who are pregnant and\u002For breastfeeding\n   * Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods\n3. Current medications:\n\n   * Participants taking a total daily dose of benzodiazepines greater than the equivalent of 6mg\u002Fday of lorazepam\n   * Participants on complementary and alternative medicine therapies i.e., St John's wort, Chinese medicines, and various herbal and homeopathic treatments\n4. Stimulants\n\n   * Participants taking stimulants such as methylphenidate, amphetamine, and dextroamphetamine for a diagnosis such as ADHD can still have Esketamine provided they do not continue taking stimulants concurrently for the duration of the study.\n   * Concurrent use is excluded due to the synergistic effect with Esketamine that can cause increased blood pressure.\n5. Medical history:\n\n   * Participants with current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)\n   * Participants with a history of uncontrolled hypertension\n   * Participants with uncontrolled diabetes mellitus\n   * Participants with aneurysmal vascular disease including thoracic and abdominal aorta, intracranial and peripheral arterial vessels, or arteriovenous malformation, intracerebral haemorrhage\n   * Participants with untreated glaucoma, current penetrating or perforating eye injury, brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure or increased intraocular pressure or planned eye surgery\n   * Participants who are currently receiving electroconvulsive therapy (ECT) or have received ECT in the past month.\n6. Substance Misuse History:\n\n   * Participants who have ever had a substance misuse disorder involving any of the following over their lifetime: ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3,4-methylenedioxy-methamphetamine (MDMA), or other hallucinogen use history\n   * Participants with hypersensitivity to Esketamine, Ketamine, or any of the excipients","ALL","18 Years","65 Years",{"count":69,"type":70},162,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are:\n\n* to investigate whether Esketamine is effective when added to ongoing antidepressant treatment\n* to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice\n\nParticipants will:\n\n* attend the clinic for supervised self-administration of intranasal Esketamine treatment\n* be observed for 2 hours following Esketamine administration including blood pressure monitoring\n* be asked to complete a battery of questionnaires\n* be reimbursed for travel expenses",[76],"Major Depressive Disorder",[78],"Depression","2026-08-10",{"date":81,"type":82},"2026-08-12","ACTUAL",{"date":84,"type":82},"2023-10-31",{"date":86,"type":70},"2028-08-15",{"name":5,"class":6},1]