RecruitingNCT06346535

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.


Sponsor

Region Östergötland

Enrollment

300 participants

Start Date

Apr 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates digital cognitive tests that can be done on a tablet or computer in a primary care setting. The goal is to see whether these tests can detect subtle thinking and memory changes in people who have recently been diagnosed with depression or stress-related exhaustion. **You may be eligible if...** - You are between 18 and 65 years old - You speak Swedish fluently and have normal or corrected-to-normal hearing and vision - You have recently received a new diagnosis of major depressive disorder (MDD) or stress-related exhaustion disorder from your primary care doctor - OR you are a healthy person with no history of depression or serious mental illness (for the comparison group) **You may NOT be eligible if...** - You are already being treated for depression or were diagnosed within the past year - You have a history of being hospitalized for mental illness - You have had a recent stroke or serious head injury - You have known cognitive impairment or a substance dependence history - You have a physical disability that prevents you from using a digital testing device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCognitive Testing

Digital Cognitive Testing performed at home.


Locations(1)

Region Ostergotland, primary care centrum

Linköping, Östergötland County, Sweden

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NCT06346535


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