[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565642":3},{"organization":4,"armGroups":7,"interventions":20,"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":54,"overallStatus":59,"whyStopped":25,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":25},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcranial magnetic stimulation","EXPERIMENTAL","Participants will receive repetitive Transcranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks. TMS will be administered by certified professionals, and patients will be monitored for any adverse events during each session. Follow-up evaluations will occur at regular intervals over the 3-year study period.",[13],"Device: Transcranial magnetic stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as usual","ACTIVE_COMPARATOR","Participants in this group will continue receiving standard care, which includes pharmacological management and psychotherapy based on clinical standards for MDD. Common medications may include selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, with dose adjustments made based on clinical response. Psychotherapy will involve cognitive-behavioral therapy or supportive therapy sessions as determined by the attending psychiatrist.",[19],"Drug: Antidepressant",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Transcranial Magnetic Stimulation (rTMS) sessions, targeting the dorsolateral prefrontal cortex, at a frequency of 10 Hz. Each session will last approximately 30 minutes, with 5 sessions per week for 4 to 6 weeks.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","Antidepressant","Selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, SNRIs",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Mohammed Al Alawi MD PhD MRCPsych ARABpsych OMSBpsych","Assistant Professor","100565642","phase-4-effective-of-transcranial-magnetic-stimulation-tms-vs-treatment-as-usual-for-first-episode-depression-in-adults-100565642",false,"NCT06644833","Effective of Transcranial Magnetic Stimulation (TMS) vs Treatment as Usual for First-Episode Depression in Adults","Effectiveness of Transcranial Magnetic Stimulation (TMS) Versus Treatment as Usual for First-Episode Depression in Adult Patients. An Open-Label Randomised Controlled Trial","Inclusion Criteria:\n\n* Adults (≥18 years old till 64 years) diagnosed with a first or second episode of unipolar major depressive disorder (MDD).\n* Moderate to severe depressive symptoms based on clinical assessment and validated scales (e.g., Hamilton Depression Rating Scale (HDRS)).\n* Willingness to participate and provide written informed consent.\n* Outpatient setting (not currently hospitalized for psychiatric reasons).\n\nExclusion Criteria:\n\n* Current episode is not the first or second episode of MDD.\n* Substance dependence or abuse within the last 6 months.\n* Diagnosed with psychotic depression, bipolar disorder, or catatonic features.\n* Severe depression requiring electroconvulsive therapy (ECT).\n* High suicidal risk as determined by clinical assessment.\n* History of unsatisfactory responses to prior TMS treatments.\n* Diagnosis of Epilepsy and Epilepsy high risk group\n* Pregnant or breastfeeding women, unless cleared by a neurologist for TMS treatment.","ALL","18 Years","64 Years",{"count":46,"type":47},120,"ESTIMATED","INTERVENTIONAL",[50],"PHASE4","This clinical trial aims to assess the effectiveness of Transcranial Magnetic Stimulation (TMS) compared to Treatment as Usual (TAU) in adult patients experiencing their first or second episode of unipolar major depressive disorder (MDD). The primary end point is to determine whether TMS leads to higher rate of remission, response and greater reductions in depression severity, and improved functional outcomes compared to standard pharmacological and psychotherapeutic interventions. The trial will also explore the impact of TMS on quality of life and anxiety symptoms. Participants will be randomly assigned to either the TMS or TAU group, and outcomes will be assessed at multiple time points over a 3-year period. The trial will be conducted at Sultan Qaboos University Hospital's Department of Behavioural Medicine in Muscat, Oman, and is expected to contribute important evidence on the role of non-invasive brain stimulation in treating early-stage depression.",[53],"Major Depressive Disorder",[55,56,57,58],"Transcranial Magnetic Stimulation,","Antidepressants","iTMS","rTMS","NOT_YET_RECRUITING","2024-10-24",{"date":62,"type":63},"2024-10-28","ACTUAL",{"date":65,"type":47},"2025-01-01",{"date":67,"type":47},"2029-06-01",{"name":5,"class":6}]