[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649477":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biological sample collection for iPSC\u002FhiNSC generation","EXPERIMENTAL","Includes both patients with Bipolar I or II Disorder (per DSM-5 criteria) and Human Healthy Controls (HC), recruited at the UOC of Clinical and Emergency Psychiatry, Fondazione Policlinico Universitario A. Gemelli IRCCS. All participants undergo the same peripheral blood sampling procedure, with no drug or device administered. The distinction between BD patients and healthy controls is defined by eligibility\u002Fdiagnostic criteria, not by assignment or randomization to distinct arms",[13],"Procedure: Peripheral blood sampling for PBMC isolation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Peripheral blood sampling for PBMC isolation","Blood collection in EDTA tubes for isolation of peripheral blood mononuclear cells (PBMCs), followed by reprogramming into induced pluripotent stem cells (iPSCs) via Sendai virus infection and differentiation into human induced neural stem cells (hiNSCs), used for the in vitro experiments of the protocol. No drug or device is administered to participants.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Gabriele Sani","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+39 06 30155807","gabriele.sani@policlinicogemelli.it",[31],{"facility":5,"status":20,"city":32,"state":20,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Roma","00168","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],11.10642,44.99364,{"lat":40,"lon":39},[43],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100649477","testing-a-new-gold-nanoparticle-based-lithium-delivery-method-for-bipolar-disorder-in-laboratory-models-100649477",false,"NCT07732933","Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory Models","GSK-3 as a Target for Lithium-charged Au Nanoparticles in Bipolar Disorder","GLAD","Inclusion Criteria:\n\nInclusion criteria for patients\n\n* Age: 18-65 years.\n* Diagnosis of Bipolar I or Bipolar II Disorder, according to DSM-5 criteria.\n* Currently in a depressive, manic, hypomanic, mixed, or euthymic phase, as defined by DSM-5 and clinical evaluation.\n* No use of psychotropic medications during the 12 months preceding enrollment, except for low-dose benzodiazepines or antipsychotics used intermittently to manage sleep disturbances or anxiety symptoms.\n* No prior treatment with lithium at any point in the patient's psychiatric history.\n* Medically stable and deemed suitable for study participation.\n* Ability and willingness to provide written informed consent before any study procedure For the Human Healthy Control group\n* participants aged 18-65 years will be included, while subjects with DSM-5 disorders or a family history of psychiatric disorders will be excluded.\n\nExclusion Criteria:\n\n* Current or past diagnosis of schizophrenia, schizoaffective disorder, or borderline personality disorder as the primary psychiatric condition.\n* Diagnosis of moderate to severe substance use disorder (excluding nicotine) within the past 12 months.\n* Active suicidal ideation with plan or intent\n* History of major neurological disorders, including epilepsy, traumatic brain injury, or neurodegenerative disease.\n* Previous exposure to lithium at any point in the individual's psychiatric history.\n* Use of psychotropic medication within the 12 months before enrollment.\n* Presence of uncontrolled or clinically significant medical conditions, including but not limited to severe hepatic, renal, or cardiovascular disease.",true,"ALL","18 Years","65 Years",{"count":59,"type":60},20,"ESTIMATED","INTERVENTIONAL",[63],"NA","This preclinical translational study aims to evaluate a new method of delivering lithium using gold nanoparticles for the treatment of bipolar disorder. Lithium is an effective treatment for bipolar disorder, but its clinical use is limited by a narrow therapeutic range and the risk of side effects. The study will investigate whether gold nanoparticles carrying lithium can improve lithium delivery to brain cells while reducing exposure to other tissues.\n\nThe research will use human induced pluripotent stem cell (iPSC)-derived neural cells generated from blood samples collected from people with bipolar disorder and healthy volunteers, as well as a mouse model of mania. No participants will receive the investigational treatment. Human participants will provide blood samples only for the generation of laboratory cell models.\n\nThe study will compare the effects of nanoparticle-delivered lithium with conventional lithium salts on cellular lithium uptake, disease-related molecular and functional changes, and biomarkers associated with bipolar disorder. The hypothesis is that lithium delivered by gold nanoparticles will achieve greater therapeutic effects at lower systemic lithium exposure than conventional lithium formulations, providing proof of concept for a safer and more targeted lithium delivery strategy for future clinical development.",[66,67],"Bipolar Disorder (BD)","Bipolar Disorder (BPD)","NOT_YET_RECRUITING","2026-07-27",{"date":71,"type":72},"2026-07-29","ACTUAL",{"date":74,"type":60},"2026-10-01",{"date":76,"type":60},"2029-03-31",{"name":5,"class":6},1]