Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06346535

PrimeCog: Primary Care Cognitive Testing

Led by Region Östergötland · Updated on 2024-04-23

300

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PrimeCog: Primary Care Cognitive Testing

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 to 65 years old
  • Fluent in Swedish
  • Corrected to normal vision and hearing
  • Newly diagnosed with major depressive disorder (MDD) or stress-induced exhaustion disorder (SED) according to DSM-V (MDD) and Swedish Board of Health and Welfare (SED) criteria
Not Eligible

You will not qualify if you...

  • Ongoing treatment for MDD/SED or previous diagnosis of MDD/SED within the last year
  • History of serious mental illness requiring psychiatric in-patient care
  • Acute cerebrovascular event or severe head trauma in the last 6 months
  • Known cognitive impairment
  • Substance dependence, ongoing or past
  • Motor disability affecting interaction with digital tests
  • Photosensitive epilepsy or migraines
  • Any contraindication to MRI for participants in the MRI subgroup

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Region Ostergotland, primary care centrum

Linköping, Östergötland County, Sweden

Actively Recruiting

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Research Team

H

Hanna Israelssion Larsen, PhD

CONTACT

A

Anna Segernäs, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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