[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657482":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":38,"armGroups":50,"interventions":63,"overallOfficials":38,"centralContacts":71,"locations":77,"responsibleParty":146,"collaborators":150,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":155,"sex":161,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":38,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":177,"whyStopped":38,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Jawaharlal Institute of Postgraduate Medical Education & Research","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Hamilton Depression Rating Scale (HAM-D)","Endpoint HAM-D scores. Minimum 0 and maximum 52. Higher scores denote worse outcomes.","End of study week 3 (±2 days)",[14,16,20,23,27,30,34],{"measure":10,"description":11,"timeFrame":15},"Study day 2 (± 1 day), day 7 (± 1 day), and the end of study weeks 2 (± 1 day) and week 4 (±2 days)",{"measure":17,"description":18,"timeFrame":19},"Montgomery-Asberg Depression Rating Scale (MADRS)","Endpoint MADRS scores. Minimum 0 and maximum 60. Higher scores denote worse outcomes.","End of study day 2 (± 1 day), day 7 (± 1 day), end of study week 2 (±1 day), week 3 (± 2 days), and week 4 (± 2 days)",{"measure":21,"description":22,"timeFrame":19},"Patient Health Questionnaire (PHQ)-9","Endpoint PHQ scores. Minimum 0 and maximum 27. Higher scores denote worse outcomes.",{"measure":24,"description":25,"timeFrame":26},"Hamilton Depression Rating Scale (HAM-D)\u002FMontgomery-Asberg Depression Rating Scale (MADRS)","Response and remisssion rates. HAM-D-Minimum 0 and maximum 52. MADRS-Minimum 0 and maximum 60.For both scales, higher scores denote worse outcomes.","End of study week 2 (±1 day), week 3 (± 2 days), and week 4 (± 2 days)",{"measure":28,"description":29,"timeFrame":26},"Visual Analogue Scale for self-rated functioning & quality of life","Percentage change from baseline. Scores range from 0 to 100. Higher scores denote better outcome.",{"measure":31,"description":32,"timeFrame":33},"Intrasession adverse effects checklist","Proportion and frequency of adverse effects. Checklist used for adverse effects.","During each treatment session until the end (at 2 hours)",{"measure":35,"description":36,"timeFrame":37},"Systematic assessment for treatment-emergent effects (SAFTEE) checklist","Proportion and frequency of adverse effects. Checklist used for the systematic assessment of side effects in clinical trials","At study day 2 (± 1 day), day 7 (± 1 day), end of study week 2 (±1 day), week 3 (± 2 days), and week 4 (± 2 days)",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":45},"TRIPLE",[46,47,48],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Background: Conventional antidepressant treatment for major depressive episodes typically requires 3-6 weeks of drug use before meaningful clinical improvement is noted. Consequently, patients have to put their lives and responsibilities on hold while waiting for a therapeutic response.\n\nProblem statement and rationale: There is a distinct need for a safe, acceptable, and effective, rapidly acting antidepressant in MDE to limit the impact on daily life. As an inexpensive, generic medication administered through a convenient route, oral ketamine has the potential to overcome the logistical barriers associated with existing ketamine formulations. If proven effective in a rigorous multicenter randomized controlled trial (RCT), oral ketamine would provide an affordable, scalable, and pragmatic intervention suitable for integration into routine psychiatric services.\n\nObjectives- Primary: To assess the efficacy of adjunctive oral ketamine vs oral midazolam on clinical depression ratings at the end of study week 3- primary endpoint assessed using Hamilton Depression rating scale.\n\nSecondary:\n\nTo assess the efficacy of adjunctive oral ketamine vs oral midazolam on clinical depression ratings at study day 2, day 7, and end of study weeks 2 and 4 and suicide ideation ratings at study day 2, study day 7, end of study week 2, week 3, and week 4.\n\nTo assess the efficacy of adjunctive oral ketamine vs oral midazolam on between-group response and remission rates, self-rated functioning, and self-rated quality of life at the end of study week 2, week 3, and week 4.\n\nTo compare psychophysiological and adverse effects between groups during each treatment session until the end (at 2 hours) and to compare adverse effects between groups at study day 2, day 7, and the end of study week 2, week 3, and week 4.\n\nMethodology: This study uses a randomized, double-blind, active-placebo controlled, multicenter, RCT design to compare the efficacy and safety of repeated dosing with adjunctive oral ketamine vs oral midazolam in patients with moderate to severe MDE. Safety and efficacy endpoints will be assessed by separate outcome raters.\n\nExpected outcomes: This study will establish an indigenous, cost-effective therapeutic strategy that could improve accessibility, hasten therapeutic response, and inform treatment guidelines, if found to be safe and effective.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Oral midazolam","PLACEBO_COMPARATOR","The comparator arm will receive flexibly-dosed oral midazolam (5-7.5mg across all nine sessions, guided based on psychophysiological response to preserve the integrity of blinding), which will also be administered in approximately 200 mL of water, and sipped across 20-30 minutes",[56],"Drug: Oral midazolam",{"label":58,"type":59,"description":60,"interventionNames":61},"Oral ketamine","EXPERIMENTAL","In the first session, oral ketamine will be administered as a fixed 150 mg dose diluted in approximately 200 mL water and sipped across 20-30 minutes. In sessions 2-9 for oral ketamine, the dose will be lowered to 100-125mg in those who do not tolerate 150mg. If patients tolerate the first session well, the dose of ketamine will be increased to 175mg in the second session. If there is a negligible benefit and the intervention is tolerated, the dose of ketamine will be increased to 200 mg in the third session.\n\nFurther increase in ketamine will be done in the last week to 250mg, if deemed necessary, due to suboptimal response. Participants will remain nil per oral from one hour before until two hours after each session. Blood pressure and pulse rate will be monitored every 15 minutes for one hour or until normalization. Benzodiazepines such as clonazepam will be permitted for anxiety or agitation",[62],"Drug: Oral ketamine",[64,68],{"type":65,"name":58,"description":66,"armGroupLabels":67,"otherNames":38},"DRUG","Nine sessions of oral ketamine",[58],{"type":65,"name":52,"description":69,"armGroupLabels":70,"otherNames":38},"Nine sessions of oral midazolam",[52],[72],{"name":73,"role":74,"phone":75,"phoneExt":38,"email":76},"Vikas Menon, MD","CONTACT","+91 8098158528","drvmenon@gmail.com",[78,95,108,122,136],{"facility":79,"status":38,"city":80,"state":81,"zip":38,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"NIMHANS","Bangalore","Karnataka","India","IN",{"type":85,"coordinates":86},"Point",[87,88],77.59369,12.97194,{"lat":88,"lon":87},[91],{"name":92,"role":74,"phone":93,"phoneExt":38,"email":94},"Suhas Satish","+91 8884493142","suhas.academic@gmail.com",{"facility":96,"status":38,"city":97,"state":81,"zip":38,"country":82,"countryCode":83,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Kasturba Medical College","Udupi",{"type":85,"coordinates":99},[100,101],74.74617,13.33467,{"lat":101,"lon":100},[104],{"name":105,"role":74,"phone":106,"phoneExt":38,"email":107},"Samir K Praharaj","+91 8971026304","samirpsyche@yahoo.co.in",{"facility":109,"status":38,"city":110,"state":111,"zip":38,"country":82,"countryCode":83,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"MGM Medical College, Mumbai","Mumbai","Maharashtra",{"type":85,"coordinates":113},[114,115],72.88261,19.07283,{"lat":115,"lon":114},[118],{"name":119,"role":74,"phone":120,"phoneExt":38,"email":121},"Sagar Karia","+91 9594530457","karia777@yahoo.com",{"facility":123,"status":38,"city":124,"state":125,"zip":38,"country":82,"countryCode":83,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"AIIMS, Bhubaneswar","Bhubaneswar","Odisha",{"type":85,"coordinates":127},[128,129],85.83385,20.27241,{"lat":129,"lon":128},[132],{"name":133,"role":74,"phone":134,"phoneExt":38,"email":135},"Susanta K Padhy","+91 9463895852","psych_susanta@aiimsbhubaneswar.edu.in",{"facility":137,"status":38,"city":138,"state":138,"zip":38,"country":82,"countryCode":83,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Jawaharlal Institute of Postgraduate Medical Education and Research","Puducherry",{"type":85,"coordinates":140},[141,142],79.82979,11.93381,{"lat":142,"lon":141},[145],{"name":73,"role":74,"phone":75,"phoneExt":38,"email":76},{"type":147,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Dr. Vikas Menon","Professor",[151],{"name":152,"class":6},"Indian Council of Medical Research","100657482","phase-3-a-study-comparing-oral-ketamine-with-oral-midazolam-for-the-treatment-of-major-depressive-episodes-100657482",false,"NCT07839338","A Study Comparing Oral Ketamine With Oral Midazolam for the Treatment of Major Depressive Episodes","A Randomized, Double-blind, Active Placebo-controlled, Multicenter Trial of Efficacy and Safety of Adjunctive Oral Ketamine vs Oral Midazolam for Major Depressive Episodes","KOMET","Inclusion Criteria:\n\n* Consenting adult outpatients or inpatients with at least moderately severe major depressive episode (MDE), denoted by HAM- D more than or equal to 20, associated with major depressive disorder or bipolar disorder, with diagnosis confirmed using a structured diagnostic interview.\n\nExclusion Criteria:\n\n* Patients with co-morbid obsessive-compulsive disorder or intellectual disability disorder or co-morbid substance dependence other than nicotine or patients concurrently receiving neuromodulation treatments or those with psychotic symptoms. Patients with current or ongoing suicide risk, such as active suicidal ideation with a specific plan or some intent in the last 3 days, will be excluded if they are treated as outpatients. Patients in whom, in the subjective opinion of the PI, the MDE symptoms appear to be significantly driven by acute life events or circumstances. Patients with abnormalities of concern detected in the electrocardiogram, or with uncontrolled hypertension or those with ongoing pregnancy or lactation","ALL","18 Years","65 Years",{"count":165,"type":166},220,"ESTIMATED","INTERVENTIONAL",[169],"PHASE3","Patients with depression are acutely distressed, often suicidal, and unable to meet the demands of everyday life. If proven effective in a rigorously conducted multicenter randomized controlled trial (RCT), oral ketamine would provide an affordable and scalable, intervention suitable for integration into routine psychiatric services.This study will establish an indigenous, cost-effective therapeutic strategy that could improve accessibility, hasten therapeutic response, and inform treatment guidelines, if found to be safe and effective.",[172],"Major Depressive Episode",[174,175,176],"oral ketamine","major depressive episodes","oral midazolam","NOT_YET_RECRUITING","2026-09-28",{"date":180,"type":181},"2026-10-01","ACTUAL",{"date":183,"type":166},"2026-10",{"date":185,"type":166},"2029-10",{"name":5,"class":6},5]