Recruiting

PrimeCog: Primary Care Cognitive Testing

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…

ClinicalTrials.gov IDNCT06346535
PhaseNot Applicable
Enrollment300
SponsorRegion Östergötland
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Mental Health Issue, Cognitive Symptom, Primary Health Care

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.