[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590529":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":23,"responsibleParty":35,"collaborators":23,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":23,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":61,"whyStopped":23,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":23},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neurodevelopmental alteration","EXPERIMENTAL","blood sampling to generate organoids in the ND group",[13],"Other: blood sample",{"label":15,"type":16,"description":17,"interventionNames":18},"No Neurodevelopmental alteration","PLACEBO_COMPARATOR","blood sampling to generate organoids in the non- ND group",[13],[20],{"type":6,"name":21,"description":21,"armGroupLabels":22,"otherNames":23},"blood sample",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"François CREMIEUX","Director of the AP-HM","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},"Antoine LEFRERE","CONTACT","+33491744013","antoine.lefrere@ap-hm.fr",{"type":36,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100590529","analysis-of-early-neurodevelopmental-alterations-in-bipolar-disorder-based-on-cortical-organoid-models-100590529",false,"NCT06968598","Analysis of Early Neurodevelopmental Alterations in Bipolar Disorder Based on Cortical Organoid Models","BIPODEV","Inclusion Criteria:\n\n* Presence of bipolar disorder according to DSM-5 criteria\n* Able to freely give and sign consent\n* Affiliated or beneficiary of a health insurance plan\n* Previous participants in the NEMO study (2022-A00353-40)\n\nFor the \"neurodevelopmental bipolar\" (ND-BP) group: presence of a neurodevelopmental burden score in the top 5, as assessed in the NEMO project (NCT05674019).\n\nFor the \"non-neurodevelopmental bipolar\" group (TB): presence of a neurodevelopmental load score of 0, or in the lowest 5, as assessed in the NEMO project.\n\nExclusion Criteria:\n\n* \\- Presence of a severe symptomatic or unstable physiological or medical condition (including pregnancy)\n* History of psychiatric illness (stable or not), schizophrenia or any other pathology likely to interfere with bipolar disorder\n* History of severe head trauma (GCS\\\u003C8 at time of trauma)\n* Presence of a neurological disorder affecting central nervous system function\n* Presence of moderate to severe substance use disorders (\\>=4\u002F11 as defined in DSM-5), with the exception of tobacco use disorders.\n* The volunteer is under court protection or guardianship\n* It proves impossible to give the volunteer informed information, or the volunteer refuses to sign the consent form.\n* Insufficient command of the French language to complete evaluations","ALL","18 Years","60 Years",{"count":48,"type":49},10,"ESTIMATED","INTERVENTIONAL",[52],"NA","Demonstrate the existence of neurodevelopmental alterations in organoids derived from samples of patients with bipolar disorder (BD) with a neurodevelopmental (ND) component, compared with patients with bipolar disorder (BD) without an ND component.",[55,56,57],"Bipolar Disorder (BD)","Organoids","Neurodevelopmental Conditions",[59,60],"organoid","neurodevelopmental alterations","NOT_YET_RECRUITING","2025-05-05",{"date":64,"type":65},"2025-05-13","ACTUAL",{"date":67,"type":49},"2025-06-01",{"date":69,"type":49},"2030-02-01",{"name":5,"class":6}]