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