[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"central-nervous-system-agents\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:central-nervous-system-agents":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":5},"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"]