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Search / Trial NCT06346535

PrimeCog: Primary Care Cognitive Testing

Launched by REGION ÖSTERGÖTLAND · Mar 28, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

The PrimeCog study is exploring how stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) affect mental health compared to healthy individuals. Researchers want to understand the differences in symptoms and brain function by collecting samples of blood, saliva, and hair, and using digital questionnaires and cognitive tests that participants can complete at home. After 12 and 24 months, participants will also undergo brain scans (MRIs) to help identify any changes over time. The goal is to develop better ways to diagnose and treat these conditions based on what researchers learn about the brain and body.

To participate in this study, you should be between 18 and 65 years old, speak Swedish, and have normal vision and hearing. Eligible participants must have recently received a diagnosis of either MDD or SED. However, if you have been treated for these conditions in the past year, have a serious mental illness, or have certain other medical issues, you may not qualify. If you join, you can expect to share your health information and undergo several tests, helping researchers gain valuable insights into these mental health disorders.

Gender

ALL

Eligibility 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.

About Region östergötland

Region Östergötland is a prominent healthcare organization in Sweden dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, the region provides a robust infrastructure for conducting high-quality studies across various therapeutic areas. With a focus on ethical standards and patient safety, Region Östergötland aims to contribute to the development of new therapies and enhance the quality of care within the community and beyond. Its strategic initiatives prioritize translational research and the effective integration of scientific advancements into clinical practice.

Locations

Linköping, Ostergotland, Sweden

Patients applied

0 patients applied

Trial Officials

Hanna Israelsson Larsen, PhD

Principal Investigator

Region Ostergotland/Linkoping University

Anna Segernas, PhD

Principal Investigator

Region Ostergotland/Linkoping University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported