[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577974":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":31,"collaborators":20,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":20,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":20,"enrollmentInfo":44,"targetDuration":20,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":55,"overallStatus":59,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":20},{"fullName":5,"class":6},"University of Salerno","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FOG-PD","EXPERIMENTAL","FOG-PD will receive vortioxetine",[13],"Drug: Vortioxetine (tablet)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Vortioxetine (tablet)","Vortioxetine will be used with the aim of treating freezing of gait in subjects with Parkinson Disease and depressive symptoms",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Marianna Amboni, Professor","CONTACT","+393358274695","mamboni@unisa.it",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Federico Di Filippo, Doctor","+393519398297","federicodifilippo@hotmail.it",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Marianna Amboni","Professor","100577974","phase-4-vortioxetine-for-depressive-symptoms-and-freezing-of-gait-in-parkinson-disease-100577974",false,"NCT06805266","Vortioxetine for Depressive Symptoms and Freezing of Gait in Parkinson Disease","An Open Study to Evaluate the Efficacy of Vortioxetine on Freezing of Gait in Patients Affected by Parkinson Disease with Depressive Symptoms","Inclusion Criteria:\n\n1. Diagnosis of PD according to published criteria\n2. Occurrence of depression according to Beck Depression Inventory II (score ≥ 15)\n3. A score ≥ 2 on the freezing question #2.13 of part 2 of the MDS-UPDRS (moderate-severe FOG).\n4. FOG not responsive to dopaminergic treatment.\n\nExclusion Criteria:\n\n1. Treatment with IMAO-B (rasagiline, selegiline, safinamide) (to be included, IMAO-B need to be withdrawn for at least 15 days)\n2. Concomitant treatment with other antidepressant drugs\n3. Hepatic and renal insufficiency\n4. Treatment with tramadol or triptans\n5. Psychotic disorder\n6. Dementia according to DSM-V","ALL","18 Years",{"count":45,"type":46},40,"ESTIMATED","INTERVENTIONAL",[49],"PHASE4","The present study involves patients with Parkinson Disease (PD) suffering from freezing of gait (FOG) and depressive symptoms. The main aim of the study is evaluating the efficacy of vortioxetine in reducing moderate\u002Fsevere FOG not responsive to dopaminergic treatment in patients with PD with depressive symptoms.",[52,53,54],"Parkinson Disease, Idiopathic","Freezing of Gait","Depression Not Otherwise Specified",[56,57,58],"Parkinson Disease","freezing of gait","depression NOS","NOT_YET_RECRUITING","2025-02-03",{"date":62,"type":63},"2025-02-06","ACTUAL",{"date":65,"type":46},"2025-02",{"date":67,"type":46},"2027-02",{"name":33,"class":6}]