[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542720":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":10,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":10,"studyType":82,"phases":10,"briefSummary":83,"conditions":84,"keywords":10,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Region Östergötland","OTHER",[8,12,17],{"label":9,"type":10,"description":11,"interventionNames":10},"Case1",null,"Individuals diagnosed with major depressive disorder (MDD)",{"label":13,"type":10,"description":14,"interventionNames":15},"Case2","Individuals diagnosed with stress induced exhaustion disorder (SED)",[16],"Diagnostic Test: Cognitive Testing",{"label":18,"type":10,"description":19,"interventionNames":20},"Control","Healthy Controls (HC) (i.e. individuals without symptoms of MDD or SED)",[16],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"DIAGNOSTIC_TEST","Cognitive Testing","Digital Cognitive Testing performed at home.",[13,18],[28,32],{"name":29,"affiliation":30,"role":31},"Hanna Israelsson Larsen, PhD","Region Ostergotland\u002FLinkoping University","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":30,"role":31},"Anna Segernas, PhD",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Hanna Israelssion Larsen, PhD","CONTACT","+46738317008","hanna.israelsson.larsen@regionostergotland.se",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Anna Segernäs, PhD","+46733641430","anna.segernas@liu.se",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":10,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Region Ostergotland, primary care centrum","RECRUITING","Linköping","Östergötland County","Sweden","SE",{"type":53,"coordinates":54},"Point",[55,56],15.62157,58.41086,{"lat":56,"lon":55},[59,61,62,63],{"name":29,"role":37,"phone":60,"phoneExt":10,"email":39},"0738317008",{"name":33,"role":37,"phone":42,"phoneExt":10,"email":43},{"name":29,"role":31,"phone":10,"phoneExt":10,"email":10},{"name":41,"role":31,"phone":10,"phoneExt":10,"email":10},{"type":31,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Hanna Israelsson Larsen","Principal Investigator","100542720","primecog-primary-care-cognitive-testing-100542720",false,"NCT06346535","PrimeCog: Primary Care Cognitive Testing","PrimeCog: Cognitive Profile, Psychosocial Characteristics, Brain MRI and Biomarkers for Stress and Neurodegeneration in Patients With Depression or Stress Induced Exhaustion Disorder in Primary Care.","PrimeCog","Inclusion Criteria:\n\n1. adults 18 to 65 years old;\n2. fluent in Swedish;\n3. corrected to normal vision and hearing;\n4. (for cases), newly diagnosed with MDD or SED (i.e., received as new diagnosis at the visit to the physician) according to the diagnostic criteria from DSM-V (MDD) and the Swedish Board of Health and Welfare (SED)\n\nExclusion Criteria:\n\n1. already ongoing treatment for MDD\u002FSED or previous diagnosis of MDD\u002FSED within the last year;\n2. history of serious mental illness (defined as mental illness that has required psychiatric in-patient care);\n3. acute cerebrovascular event or severe head trauma in the last 6 months;\n4. known cognitive impairment;\n5. substance dependence, ongoing or past;\n6. motor disability or impairment affecting interaction with the digital tests;\n7. photosensitive epilepsy or -migraines.\n\nFor the MRI subgroup, any contraindication to MRI is an exclusion criterion.",true,"ALL","18 Years","65 Years",{"count":80,"type":81},300,"ESTIMATED","OBSERVATIONAL","The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD\u002FSED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated.",[85,86,87],"Mental Health Issue","Cognitive Symptom","Primary Health Care","2024-04-19",{"date":90,"type":91},"2024-04-23","ACTUAL",{"date":93,"type":91},"2024-04-01",{"date":95,"type":81},"2029-04-01",{"name":5,"class":6},1]