[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651453":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":31,"collaborators":25,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":25,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":25,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":25,"overallStatus":54,"whyStopped":25,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":25},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute iTBS + Maintenance iTBS + Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Arm 1 (aiTBS + TAU) Accelerated iTBS will be provided with a 100X transcranial magnetic stimulator with a 70 mm active cooled figure of eight coil. The parameters to be given are 3 pulses, frequency- 50 Hz bursts, 2 seconds on and 10 seconds off for 3 minutes and a total of 600 pulses per session. Each patient will receive 5 sessions per week for 4 weeks with a total of 20 sessions. Considering the high frequency of stimulation a round of three iTBS per treatment will be given separated by 15minutes, a total of 1800 pulses per day. The sessions will be given after calculating a resting motor threshold. Stimulation target will be dorsolateral prefrontal cortex.",[13],"Device: Transcranial Magnetic Stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Acute iTBS + Quetiapine + Treatment as Usual (TAU)","The active intervention consists of Quetiapine Extended-Release (XR) administered once daily. Treatment will be individually tailored to patient requirements, with the daily maintenance dose adjusted between 100 mg and 200 mg based on clinical efficacy and side-effect tolerability.",[18],"Drug: quetiapine",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcranial Magnetic Stimulation","Treatment Schedule: After completion of acute treatment with rTMS, Patients will receive 5 days of treatment (as per previously mentioned schedule) per week for one week only in a month for maintenance sessions, for a total patient treatment duration of 3 months.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","quetiapine","After completion of acute course of rTMS, Patients will receive Quetiapine as a pharmacological augmentation to their standard TAU, dosed and titrated as per standard clinical guidelines for Treatment-Resistant Depression.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Dr. Debadatta Mohapatra","ASSOCIATE PROFFESOR","100651453","phase-3-study-of-rtms-in-maintenance-in-treatment-resistant-depression-100651453",false,"NCT07760168","Study of rTMS in Maintenance in Treatment Resistant Depression","Efficacy and Safety of Acute Followed by Maintenance rTMS in Treatment Resistant Depression: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients of both genders, between the ages 18- 60 years\n2. Clinically diagnosed as depression according to ICD-11.\n3. Diagnosis of treatment resistance depression according to US-FDA.\n4. On stable dosing of antidepressant venlafaxine 150 mg per day.\n5. Right-handed.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Any kind of psychiatric emergency (E.g., Suicide risk, Catatonia, aggression or excitement)\n3. Any co-morbid neurological disease\n\n   1. History of seizure\u002F epilepsy.\n   2. History of migraine.\n   3. History of head trauma\u002F organic brain condition.\n4. Any contraindications to rTMS procedure:\n\n   1. Metallic or electronic implants in the brain or heart, or any cochlear implants\n   2. Injury or local lesion in the scalp\u002Fhead.","ALL","18 Years","60 Years",{"count":46,"type":47},68,"ESTIMATED","INTERVENTIONAL",[50],"PHASE3","The goal of this clinical trial is to learn which treatment works better to help people with treatment-resistant depression stay well after they improve with repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment. It will also learn about the safety of maintenance rTMS and maintenance quetiapine.\n\nThe main questions it aims to answer are:\n\nDoes maintenance rTMS help prevent depression from returning better than maintenance quetiapine? Do participants receiving maintenance rTMS have greater improvement in depression symptoms over time than those receiving maintenance quetiapine? What side effects or medical problems occur with each treatment?\n\nResearchers will compare maintenance rTMS with maintenance quetiapine after all participants have completed the initial course of rTMS.\n\nParticipants will:\n\nReceive an initial course of rTMS. Be randomly assigned to receive either maintenance rTMS or maintenance quetiapine.\n\nAttend regular follow ups to assess depression symptoms with MADRS , assess overall improvement by CGI , and any side effects.\n\nProvide blood samples at selected visits to measure brain-derived neurotrophic factor (BDNF), a protein that may be be linked to recovery from depression.\n\nBe followed for several months to monitor whether their depression returns and how well they continue to improve.",[53],"Treatment Resistant Depression (TRD)","NOT_YET_RECRUITING","2026-08-07",{"date":57,"type":58},"2026-08-12","ACTUAL",{"date":60,"type":47},"2026-08-30",{"date":62,"type":47},"2028-08-30",{"name":5,"class":6}]