Actively Recruiting
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
Led by Region Östergötland · Updated on 2024-04-23
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying major depressive disorder (MDD) and stress-induced exhaustion disorder (SED), two common mental health conditions in primary care that affect cognition and work productivity. This study aims to understand the symptoms and biological changes in these disorders compared to healthy individuals. By exploring differences in brain imaging, cognitive function, and biomarkers, the research seeks to improve diagnosis and tailor treatments more effectively. Participants include groups newly diagnosed with MDD or SED and healthy controls. The study collects data through digital cognitive tests done at home, questionnaires about psychosocial factors, and samples of blood, saliva, and hair. Brain MRI scans are also performed. These assessments are repeated at baseline, 12 months, and 24 months to track changes over time. During the study, participants will complete cognitive tests focused on attention, memory, and executive function. Researchers will analyze brain MRI images and biomarkers related to stress, inflammation, and neurodegeneration. The study measures how symptoms relate to cognitive and biological findings. Participation lasts for two years with evaluations at three time points, helping to understand the progression and differences between MDD and SED.
CONDITIONS
Brief Title
PrimeCog: Primary Care Cognitive Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 65 years old
- Fluent in Swedish
- Normal or corrected vision and hearing
- Newly diagnosed with major depressive disorder (MDD) or stress-induced exhaustion disorder (SED) according to official diagnostic criteria
You will not qualify if you...
- Ongoing treatment or diagnosis of MDD or SED within the last year
- History of serious mental illness requiring psychiatric hospital care
- Acute stroke or severe head injury in the past 6 months
- Known cognitive impairment
- Current or past substance dependence
- Motor disability affecting use of digital tests
- Photosensitive epilepsy or migraines
- Any contraindication to MRI for those in the MRI subgroup
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline, 12 months, and 24 months
Participants complete digital cognitive testing at home and undergo brain MRI and collection of blood, saliva, and hair samples to measure cognitive function and biomarkers.
3 assessments (combination of at-home testing and in-person visits for MRI and sample collection)
Duration - 24 months
Participants are observed over 24 months to assess changes in cognitive function and biomarkers related to depression or stress-induced exhaustion disorder.
Follow-up assessments at 12 and 24 months after baseline
Trial Site Locations
Total: 1 location
1
Region Ostergotland, primary care centrum
Linköping, Östergötland County, Sweden
Actively Recruiting
Research Team
H
Hanna Israelssion Larsen, PhD
A
Anna Segernäs, PhD
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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