[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571007":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":11,"responsibleParty":41,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":11},{"fullName":5,"class":6},"University of Catania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"active","EXPERIMENTAL",null,[13],"Device: Active tDCS",{"label":15,"type":16,"description":11,"interventionNames":17},"sham","SHAM_COMPARATOR",[18],"Device: Sham treatment",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Active tDCS","The active tDCS protocol consist of 15 excitatory tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC at an intensity of 2 mA. The electrodes are positioned according to the 10-20 electroencephalography system (Anode on F3 and Cathode on F4).",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Sham treatment","The sham-tDCS intervention consist of a placebo 15 tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC. During the sessions only a 15-second initiation current is applied, providing the patient with the sensation of receiving an electric current on the scalp. Participants will also experience sounds and stimuli similar to those produced by active tDCS.",[15],[30],{"name":31,"affiliation":5,"role":32},"Maria Salvina Signorelli, MD PhD","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","3498127364","maria.signorelli@unict.it",{"name":39,"role":35,"phone":11,"phoneExt":11,"email":40},"Carmen Concerto, MD PhD","c.concerto@policlinico.unict.it",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Carmen Concerto","PhD, MD","100571007","non-invasive-brain-stimulation-in-subjects-with-major-depressive-disorder-100571007",false,"NCT06714643","Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder","Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder","NIBS_tDCS","Inclusion criteria:\n\n* Patients with Major Depressive Disorder (MDD), as defined by the DSM-5-TR criteria;\n* Presence of residual symptoms, defined by a Hamilton Depression Rating Scale score over 7;\n* Age over 18 years.\n\nExclusion criteria:\n\n* MMSE under 18 and\u002For CDR over 2;\n* Other neurological diseases (stroke, multiple sclerosis, major head trauma, epilepsy) or psychiatric disorders other than those included (schizophrenia, bipolar disorder, etc.);\n* Patients with severe clinical conditions, acute or uncontrolled chronic medical diseases;\n* Endocrine diseases, vitamin deficiencies, or exposure to drugs associated with cognitive impairment and\u002For mood deflection;\n* Alcohol abuse or recreational drug use;\n* Contraindications to MRI and TMS (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy);\n* Pregnant or breastfeeding women.","ALL","19 Years",{"count":56,"type":57},105,"ESTIMATED","INTERVENTIONAL",[60],"NA","Introduction The study involves the recruitment of outpatients suffering from Major Depressive Disorder (MDD), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Patients are on selective serotonin reuptake inhibitors (SSRIs) for at least 4 weeks and present residual depressive symptoms, defined by a score greater than 7 on the Hamilton Depression Rating Scale (HDRS-17).\n\nStudy Objectives\n\nPrimary Objective To investigate the effects of transcranial direct current stimulation (tDCS) on depressive symptoms in patients with depression, randomized into a \"test\" group and a \"sham\" group.\n\nSecondary Objectives\n\nTo investigate the effects of tDCS on cognitive function in patients with depression, randomized into a \"test\" group and a \"sham\" group.\n\nTo evaluate changes in blood biomarkers, neurophysiological, and neurosonological variables after tDCS treatment in the same group of patients.",[63],"Major Depressive Disorder (MDD)",[65,66,67],"tDCS","MD","Biomarkers","NOT_YET_RECRUITING","2024-11-28",{"date":71,"type":72},"2024-12-03","ACTUAL",{"date":74,"type":57},"2025-01-02",{"date":76,"type":57},"2026-01-02",{"name":43,"class":6}]