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RECRUITING
NCT06346535

PrimeCog: Primary Care Cognitive Testing

Sponsor: Region Östergötland

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2024-04-01

Completion Date

2029-04-01

Last Updated

2024-04-23

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Cognitive Testing

Digital Cognitive Testing performed at home.

Locations (1)

Region Ostergotland, primary care centrum

Linköping, Östergötland County, Sweden