[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573936":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":72,"collaborators":43,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":43,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":43,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":109,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Maimonides Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nebulized Midazolam","ACTIVE_COMPARATOR","Midazolam used as active comparator. Dosage calculated by body weight at 0.03mg\u002Fkg",[13],"Drug: nebulized midazolam",{"label":15,"type":16,"description":17,"interventionNames":18},"Nebulized Ketamine","EXPERIMENTAL","Ketamine dosage calculated by body weight at 1.5mg\u002Fkg",[19],"Drug: nebulized ketamine",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","nebulized ketamine","The formulation of the study drug is administered via nebulizer in which the participants inhales the study drug. The dosage is calculated by body weight (1.5mg\u002Fkg).",[15],[27],"Ketalar",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"nebulized midazolam","The formulation of the active comparator drug is administered via nebulizer in which the participant inhales the study drug. The dosage is calculated by body weight (0.03mg\u002Fkg).",[9],[33],"Midazolam",[35],{"name":36,"affiliation":5,"role":37},"Theresa Jacob, PhD, MPH","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Jessica Poster, MD","CONTACT","718-283-8170",null,"JPoster@maimo.org",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Brooklyn","New York","11219","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-73.94958,40.6501,{"lat":57,"lon":56},[60,63,66,68,70],{"name":61,"role":41,"phone":42,"phoneExt":43,"email":62},"Mayank Kumar, PhD","Maykumar@maimo.org",{"name":64,"role":41,"phone":42,"phoneExt":43,"email":65},"Hasan Mustafic, BA","HMustafic@maimo.org",{"name":40,"role":67,"phone":43,"phoneExt":43,"email":43},"PRINCIPAL_INVESTIGATOR",{"name":69,"role":67,"phone":43,"phoneExt":43,"email":43},"Simran Ailani, MBBS",{"name":36,"role":71,"phone":43,"phoneExt":43,"email":43},"SUB_INVESTIGATOR",{"type":73,"investigatorFullName":36,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Director of Research","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":86,"type":87},40,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93,94,95,33,96,97,98,99,100,101,102,103,104,105,106,107,108],"Severe Depression","Moderate Depression","Ketamine","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",[5,110,95,33,96,100,111,112,113],"Psychiatry","Anesthetics, Dissociative","Nebulized Medications for depression","GABA Agents","2026-04-21",{"date":116,"type":117},"2026-04-24","ACTUAL",{"date":119,"type":117},"2024-10-16",{"date":121,"type":87},"2027-09-30",{"name":36,"class":6},1]