nctId: NCT06346535 id: 2022-05703-01 briefTitle: PrimeCog: Primary Care Cognitive Testing acronym: PrimeCog overallStatus: RECRUITING date: 2024-04-01 date: 2027-04-01 date: 2029-04-01 date: 2024-04-04 date: 2024-04-23 name: Region Östergötland class: OTHER briefSummary: 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/SED 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. conditions: Mental Health Issue conditions: Cognitive Symptom conditions: Primary Health Care studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Cognitive Testing measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding attention and processing speed measure: Cognitive Test Results regarding memory measure: Cognitive Test Results regarding memory measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding executive function measure: Cognitive Test Results regarding language measure: Cognitive Test Results regarding language measure: Cognitive Test Results regarding visuospatial capacity measure: MRI features, measured by morphological and quantitative MR sequences of the brain measure: Biochemical Profile in blood regarding inflammation, stress and neurodegeneration measure: Biochemical Profile in saliva regarding inflammation and stress measure: Biochemical Profile in hair regarding exposure to stress sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Region Ostergotland, primary care centrum status: RECRUITING city: Linköping state: Ostergotland country: Sweden name: Hanna Israelsson Larsen, PhD role: CONTACT phone: 0738317008 email: hanna.israelsson.larsen@regionostergotland.se name: Anna Segernas, PhD role: CONTACT phone: +46733641430 email: anna.segernas@liu.se name: Hanna Israelsson Larsen, PhD role: PRINCIPAL_INVESTIGATOR name: Anna Segernäs, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False