PrimeCog: Primary Care Cognitive Testing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorRegion Östergötland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adults 18 to 65 years old;
fluent in Swedish;
corrected to normal vision and hearing;
(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)
Disqualifiers
already ongoing treatment for MDD/SED or previous diagnosis of MDD/SED within the last year;
history of serious mental illness (defined as mental illness that has required psychiatric in-patient care);
acute cerebrovascular event or severe head trauma in the last 6 months;
known cognitive impairment;
Trial population
Patients and controls in primary care.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Cognitive Testing
Diagnostic testDigital Cognitive Testing performed at home.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Case10 interventions
Group B: Case21 intervention
Group C: Control1 intervention
Trial outcomes
Primary outcomes
1
Cognitive Test Results regarding attention and processing speed
How do cognitive test results regarding attention and processing speed measured by TMT-A vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)2
Cognitive Test Results regarding attention and processing speed
How do cognitive test results regarding attention and processing speed measured by TMT-B vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)3
Cognitive Test Results regarding attention and processing speed
How do cognitive test results regarding attention and processing speed measured by SDPTvary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)4
Cognitive Test Results regarding attention and processing speed
How do cognitive test results regarding attention and processing speed measured by Reaction Time Test Simple vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)Secondary outcomes
1
MRI features, measured by morphological and quantitative MR sequences of the brain
How do morphological as well as quantitative MR sequences, with and without intravenous contrast agent with following vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)2
Biochemical Profile in blood regarding inflammation, stress and neurodegeneration
How the biochemical profile in blood vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)3
Biochemical Profile in saliva regarding inflammation and stress
How the biochemical profile in saliva as described above vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)4
Biochemical Profile in hair regarding exposure to stress
How the biochemical profile in hair as described above vary between individuals with MDD/SED and HC?
Time frame
At baseline, i.e. at diagnosis, at first study-specific follow-up (12 months from baseline), and at second study-specific follow-up (24 months from baseline)Sponsors and contacts
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Source ClinicalTrials.gov