Cognitive testing for stress-induced exhaustion and depression
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.
This study is trying to see if different tests can help tell apart stress-induced exhaustion and depression in adults aged 18 to 65, to improve how we diagnose and treat these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Region Östergötland Academic / other |
| Locations | 1 site (Linköping, Östergötland County) |
| Trial ID | NCT06346535 on ClinicalTrials.gov |
What this trial studies
The PrimeCog project aims to differentiate between stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) by analyzing symptomatology and pathophysiology in comparison to healthy controls. Participants, aged 18 to 65, will be recruited from primary care centers and will undergo a series of assessments including digital cognitive tests, blood, saliva, and hair sample collection, as well as MRI scans of the brain. This multicenter longitudinal study will track changes over 12 and 24 months to identify biomarkers and cognitive differences among the groups. The goal is to develop new diagnostic tools that can guide individualized treatment strategies based on cognitive function and underlying biological mechanisms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are newly diagnosed with MDD or SED and fluent in Swedish.
Not a fit: Patients with a history of serious mental illness, ongoing treatment for MDD/SED, or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and personalized treatment strategies for patients with MDD and SED.
How similar studies have performed: While the approach of using cognitive testing and biomarkers is promising, the specific methodology of this study appears to be novel and untested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Linköping, Östergötland County
- Region Ostergotland, primary care centrum — Linköping, Östergötland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Hanna Israelsson Larsen, PhD — Region Ostergotland/Linkoping University
- Study coordinator: Hanna Israelssion Larsen, PhD
- Email: hanna.israelsson.larsen@regionostergotland.se
- Phone: +46738317008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.