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PrimeCog: Primary Care Cognitive Testing

Recruitingn/aAges 18 Years - 65 YearsAllRegion Östergötland
NCT06346535 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. adults 18 to 65 years old; 2. fluent in Swedish; 3. corrected to normal vision and hearing; 4. (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) Exclusion Criteria: 1. already ongoing treatment for MDD/SED or previous diagnosis of MDD/SED within the last year; 2. history of serious mental illness (defined as mental illness that has required psychiatric in-patient care); 3. acute cerebrovascular event or severe head trauma in the last 6 months; 4. known cognitive impairment; 5. substance dependence, ongoing or past; 6. motor disability or impairment affecting interaction with the digital tests; 7. photosensitive epilepsy or -migraines. For the MRI subgroup, any contraindication to MRI is an exclusion criterion.
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What it tests

  • Cognitive Testing
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Where

1 site
Region Ostergotland, primary care centrum
Linköping, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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