[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100276446":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":38,"centralContacts":39,"locations":48,"responsibleParty":99,"collaborators":103,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":38,"enrollmentInfo":119,"targetDuration":38,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":38,"overallStatus":51,"whyStopped":38,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Fondation FondaMental","OTHER",[8,13,16,20,23,26,29],{"label":9,"type":6,"description":10,"interventionNames":11},"acute Bipolar disorder","blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)",[12],"Genetic: Blood sampling",{"label":14,"type":6,"description":10,"interventionNames":15},"acute Schizophrenia",[12],{"label":17,"type":6,"description":18,"interventionNames":19},"stable Bipolar disorder","blood sampling and data collection (only one visit)",[12],{"label":21,"type":6,"description":18,"interventionNames":22},"stable Schizophrenia",[12],{"label":24,"type":6,"description":18,"interventionNames":25},"healthy control",[12],{"label":27,"type":6,"description":18,"interventionNames":28},"TOC",[12],{"label":30,"type":6,"description":10,"interventionNames":31},"Major Depressive Desorder",[12],[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"GENETIC","Blood sampling","supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors",[30,27,9,14,24,17,21],null,[40,45],{"name":41,"role":42,"phone":43,"phoneExt":38,"email":44},"Marion Leboyer, Pr","CONTACT","(33) 1 49 81 38 22","marion.leboyer@fondation-fondamental.org",{"name":46,"role":42,"phone":38,"phoneExt":38,"email":47},"Jean-Romain Richard","jean-romain.richard@inserm.fr",[49,62,71,76,85,91],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":53,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":38},"Psychiatry Department of Mondor Hospital","RECRUITING","Créteil","France","94000","FR",{"type":57,"coordinates":58},"Point",[59,60],2.46569,48.79266,{"lat":60,"lon":59},{"facility":63,"status":64,"city":65,"state":38,"zip":38,"country":53,"countryCode":55,"cosmosGeoPoint":66,"geoPoint":70,"contacts":38},"Psychiatry Department of Perrens Hospital","NOT_YET_RECRUITING","Bordeaux",{"type":57,"coordinates":67},[68,69],-0.58046,44.84124,{"lat":69,"lon":68},{"facility":72,"status":51,"city":52,"state":38,"zip":54,"country":53,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":75,"contacts":38},"Clinical Investigations Center of Mondor Hospital",{"type":57,"coordinates":74},[59,60],{"lat":60,"lon":59},{"facility":77,"status":51,"city":78,"state":38,"zip":79,"country":53,"countryCode":55,"cosmosGeoPoint":80,"geoPoint":84,"contacts":38},"Psychiatry Department of Widal Hospital","Paris","75010",{"type":57,"coordinates":81},[82,83],2.3488,48.85341,{"lat":83,"lon":82},{"facility":86,"status":51,"city":78,"state":38,"zip":87,"country":53,"countryCode":55,"cosmosGeoPoint":88,"geoPoint":90,"contacts":38},"EPS Maison Blanche","75020",{"type":57,"coordinates":89},[82,83],{"lat":83,"lon":82},{"facility":92,"status":51,"city":93,"state":38,"zip":38,"country":53,"countryCode":55,"cosmosGeoPoint":94,"geoPoint":98,"contacts":38},"Psychiatry Department of R. Dubos Hospital","Pontoise",{"type":57,"coordinates":95},[96,97],2.1,49.05,{"lat":97,"lon":96},{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Pr. Marion Leboyer","Responsible for Pôle de psychiatrie of Hospital Albert Chenevier- Henri Mondor",[104,106],{"name":105,"class":6},"National Research Agency, France",{"name":107,"class":6},"Assistance Publique - Hôpitaux de Paris","100276446","immuno-genetic-inflammation-retro-virus-environment-100276446",false,"NCT02878408","Immuno-Genetic, Inflammation, Retro-Virus, Environment","Immuno-Génétique, Inflammation, Retro-Virus, Environnement","I-Give","Inclusion Criteria:\n\n* Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)\n\nExclusion Criteria:\n\n* pregnant women\n* Vaccination within 4 precedent weeks\n* Severe neurologic illness\n* Immunosuppressing or immuno-modulating treatment.\n* Infectious disease within 4 precedent weeks (including HIV 1 et 2, Hepatite B, C)\n* Refuse to have HIV and hepatite B et C tests or to be informed of their results",true,"ALL","16 Years",{"count":120,"type":121},1100,"ESTIMATED","INTERVENTIONAL",[124],"NA","Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far missing in psychiatry, and to design innovative treatment approaches based on the discovery of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to be significantly associated with neuro-inflammation, the project I-GIVE will combine multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between susceptibility to environmental factors (such as winter-spring births, infections, urbanicity…) and genetic factors controlling immune responses.\n\nThus I-GIVE will allow identification of new biomarkers and their correlation with clinical profiles and immuno-inflammatory\u002Fimmuno-genetic markers, and description of patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to design innovative treatments and foster personalized psychiatry tailored to the needs of each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical model for their ability to slow, stop, or even reverse the progression of the psychosis in patients. I-GIVE project should thus lead to major results that will have strong impacts on the scientific community, pharmaceutical industries and, in a longer term, on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.",[127,128],"Bipolar Disorder","Schizophrenia","2026-05-19",{"date":131,"type":132},"2026-05-22","ACTUAL",{"date":134,"type":132},"2014-11-07",{"date":136,"type":121},"2028-11",{"name":101,"class":6},6]