[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-depression":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":44,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100573936","phase-3-nebulized-ketamine-for-the-treatment-of-major-depressive-disorder-100573936",false,"NCT06752759","Nebulized Ketamine for the Treatment of Major Depressive Disorder","Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial","Inclusion Criteria:\n\n* All individuals 18 years and older with a Montgomery-Asberg Depression Rating Scale score (MADRS) ≥ 20\n* Must have a diagnosis of moderate to severe Major Depressive Disorder (MDD)\n* Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis\n\nExclusion Criteria:\n\n* Adult patients with an allergy to Ketamine\n* Adult patients with an allergy to Midazolam\n* Individuals with a history of mania\u002Fhypomania or diagnosis of bipolar disorder\n* Patients on lithium and\u002For lamotrigine therapy\n* Recent or current homicidal ideation with an intent to act\n* MDD with psychotic features or current or past diagnosis of a psychotic disorder\n* No substance use disorder in the preceding 3 months except nicotine or caffeine or a positive urine screen for substances (except cannabis)\n* Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, intellectual disability, altered mental status, pregnant or breastfeeding patients,\n* Patients on \\> 2 medications for hypertension\n* Patients with uncontrolled hypertension (BP \\>140 mm Hg systolic and\u002For \\>90 mm Hg diastolic on two separate readings at the time of screening)\n* Body weight of \\> 150kg\n* Patients with history of congestive cardiac failure\n* Day of presentation, patients with unstable vital signs (systolic blood pressure \\\u003C90 or\\>160 mm Hg, pulse rate \\\u003C50 or \\>150 beats\u002Fmin, and respiration rate \\\u003C10 or \\>30 breaths\u002Fmin)\n* Consumption of opioids within 24 hours of drug administration\n* Acutely intoxicated patients will also be excluded","ALL","18 Years","88 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a double-blind active placebo controlled clinical trial for individuals with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Severe Depression","Moderate Depression","Ketamine","Midazolam","Peripheral Nervous System Agents","Central Nervous System Agents","Neurotransmitter Agents","Physiologic Effects of Drugs","Sensory System Agents","Analgesics, Non-Narcotic","Anti-Inflammatory Agents, Non-Steroidal","Depressive Symptom","Hypnotics and Sedatives","Anti-anxiety Agents","Tranquilizing Agents","Psychotropic Drugs","Anesthetics Agent",[45,46,29,30,31,35,47,48,49],"Maimonides Medical Center","Psychiatry","Anesthetics, Dissociative","Nebulized Medications for depression","GABA Agents","RECRUITING","2026-04-21",{"date":53,"type":54},"2026-04-24","ACTUAL",{"date":56,"type":54},"2024-10-16",{"date":58,"type":21},"2027-09-30",{"name":60,"class":61},"Theresa Jacob, PhD, MPH","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":5},"100613697","at-home-tdcs-as-maintenance-therapy-100613697","NCT07269964","At-Home tDCS as Maintenance Therapy","At-home tDCS as Maintenance Therapy Following Successful Treatment With rTMS, ECT, and Esketamine - A Pilot Study","MaintenanceDC","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode).\n* Clear indication for maintenance therapy after successful acute treatment (esketamine, rTMS, or ECT) with remission\u002Fimprovement of symptoms.\n* Capacity to provide informed consent, confirmed in a physician-led consent discussion.\n\nExclusion Criteria:\n\n* Currently in the acute treatment phase of an affective disorder and non-response to previous treatments.\n* Currently clinically relevant Axis II disorders.\n* Suicidal risk, including suicidal ideation.\n* Contraindications for tDCS: e.g., skin disease at electrode sites, cochlear implants.\n* Neurological, somatic, or psychiatric comorbidities that could compromise validity or safety.",{"count":72,"type":21},30,[74],"NA","The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment.\n\nParticipant population:\n\nAdults (18+) with depressive disorder who had already improved\u002Fstabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy).\n\nMain questions:\n\nFeasibility: Do participants reliably complete the home program and stay in the study?\n\nPreliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)?\n\nParticipants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up\u002Fdown for comfort.\n\nDuring treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks.\n\nWhere:\n\nDepartment and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich\n\nSafety \\& data privacy:\n\nThe device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.",[77,27,78],"MDD","Major Depressive Episode",[80,81,82,83,84],"Non Invasive Brain Stimulation (NIBS)","tDCS","at-home treatment","tdcs at home","transcranial direct current stimulation","2025-11-25",{"date":87,"type":54},"2025-12-08",{"date":89,"type":54},"2024-10-01",{"date":91,"type":21},"2026-11-29",{"name":93,"class":61},"Technical University of Munich"]