Clinical trial Recruiting at 1 site Observational Ages 18 to 65

Cognitive testing for stress-induced exhaustion and depression

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.

Run by Region Östergötland · NCT06346535 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment300 (estimated)
SponsorRegion Östergötland
Academic / other
Locations1 site (Linköping, Östergötland County)
StatusRecruiting
StartedApril 1, 2024
Main results expectedApril 1, 2027
Study endsApril 1, 2029
Registry record updatedApril 23, 2024
Trial IDNCT06346535 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 65 who are newly diagnosed with MDD or SED and fluent in Swedish.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Region Ostergotland, primary care centrum
    Linköping, Östergötland County, Sweden
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.