[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621981":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":19,"responsibleParty":36,"collaborators":38,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":7,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":7,"enrollmentInfo":50,"targetDuration":7,"studyType":53,"phases":7,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Aziende Chimiche Riunite Angelini Francesco S.p.A","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Raffaele Antonelli Incalzi","CAMPUS BioMedico","PRINCIPAL_INVESTIGATOR",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Alessandro Ruggieri","CONTACT","+393475665012","alessandro.ruggieri@angelinipharma.com",[20],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":24,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Poradnia Medycyna Miłorząb: pl. Pokoju 3\u002F4, 90-227 Łódź. Poland","RECRUITING","Lodz","Poland","93-005","PL",{"type":28,"coordinates":29},"Point",[30,31],19.47395,51.77058,{"lat":31,"lon":30},[34],{"name":35,"role":16,"phone":7,"phoneExt":7,"email":7},"Marcin Stanisław Wojtera, MD, PhD, Psychiatrist",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[39],{"name":40,"class":6},"IQVIA Pty Ltd","100621981","real-world-clinical-response-to-trazodone-in-italy-poland-and-romania-100621981",false,"NCT07377682","Real-world Clinical Response to Trazodone in Italy, Poland, and Romania","Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)","Inclusion Criteria:\n\n* Patients aged 55 or older.\n* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis.\n* Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment.\n* Patients with a diagnosis of MCI (also referred to as \"mild neurocognitive disorder\") according to the DSM-5 criteria.\n* Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week).\n* Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement.\n\nExclusion Criteria:\n\n* Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC.\n* Known hypersensitivity or allergy to the active ingredient and\u002For to any component of the study medication.\n* Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and\u002For proved resistance to trazodone monotherapy.\n* Patients with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition.\n* Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study.\n* Patients participating in any interventional study in the 30 days prior to the enrolment visit.\n* Patients with ongoing pregnancy or breast-feeding at enrolment visit.","ALL","55 Years",{"count":51,"type":52},120,"ESTIMATED","OBSERVATIONAL","TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania",[56,57],"Depression - Major Depressive Disorder","Cognition Disorders in Old Age",[59,60,61],"Depression","Major Depressive Disorder","Cognition","2026-01-22",{"date":64,"type":65},"2026-01-30","ACTUAL",{"date":67,"type":65},"2025-12-15",{"date":69,"type":52},"2026-07",{"name":5,"class":6},1]