[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583136":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":27,"locations":32,"responsibleParty":56,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":10,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Fondation FondaMental","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Bipolar patients",null,"Individuals diagnosed with bipolar disorder type I (BP I), bipolar disorder type II (BP II), or bipolar disorder not otherwise specified (BP NOS). Eligible participants must be between 18 and 65 years old and have had at least one contact with a mental health service in the past year. All participants will be required to provide signed informed consent before inclusion.\n\nExclusion criteria include severe psychiatric comorbidities such as schizophrenia spectrum disorders, severe cognitive impairment, or severe substance\u002Falcohol abuse, assessed using specific scores on the AUDIT and DAST scales. Patients planning to relocate within the next year will also be excluded.",[13],"Other: Blood and saliva sampling",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Blood and saliva sampling","Physical and biological evaluation at inclusion visit V0 and at follow up visit V1 (after 1 year).\n\nthe biological evaluation includes blood and saliva sampling at the 2 visits.",[9],[20,23],{"name":21,"affiliation":5,"role":22},"Marion LEBOYER, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":24,"affiliation":25,"role":26},"Ophélia GODIN, PhD","Institut National de la Santé Et de la Recherche Médicale, France","STUDY_DIRECTOR",[28],{"name":24,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","0149813326","ophelia.godain@fondation-fondamental.org",[33],{"facility":34,"status":35,"city":36,"state":10,"zip":37,"country":34,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"France","RECRUITING","Créteil","94000","FR",{"type":40,"coordinates":41},"Point",[42,43],2.46569,48.79266,{"lat":43,"lon":42},[46,50,52,54],{"name":47,"role":29,"phone":48,"phoneExt":10,"email":49},"Marion Leboyer","01 49 81 31 31","marion.leboyer@inserm.fr",{"name":51,"role":22,"phone":10,"phoneExt":10,"email":10},"Angès Pelletier",{"name":53,"role":22,"phone":10,"phoneExt":10,"email":10},"Bruno Etain",{"name":55,"role":22,"phone":10,"phoneExt":10,"email":10},"Emilie Olie",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100583136","medical-comorbidities-in-bipolar-disorder-100583136",false,"NCT06872398","Medical Comorbidities in Bipolar Disorder","Medical Comorbidities in Bipolar Disorder : Clinical Validation of Risk Factors and Biomarkers to Improve Prevention and Treatment;","BIPCOM","Inclusion Criteria:\n\n* Primary diagnosis of BP I, BP II, or BP NOS\n* Have had at least one contact with mental health services in the past year\n* Be aged between 18 and 65 years old\n* Have signed an informed consent\n\nExclusion Criteria:\n\n* Projected move within the next year.\n* Severe psychiatric comorbidities (schizophrenia spectrum disorders).\n* Severe cognitive impairment.\n* Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST.","ALL","18 Years","65 Years",{"count":70,"type":71},80,"ESTIMATED","OBSERVATIONAL","Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6). BIPCOM will be implemented through continuous consultations with stakeholders (scientific and patients' associations, users and families), for ensuring results' acceptability and transferability. The successful implementation of the project will have a significant impact upon the general health of people with BD, eventually leading to lower mortality rates and reduced incidence of severe disabilities, whilst providing reliable methods and tools for patients' stratification and personalized treatments.",[75],"Psychiatric Disorder","2025-03-10",{"date":78,"type":79},"2025-03-12","ACTUAL",{"date":81,"type":79},"2024-10-11",{"date":83,"type":71},"2026-12",{"name":5,"class":6},1]