An observational study in Mental Health Issue, Cognitive Symptom and Primary Health Care, sponsored by Region Östergötland. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Region Östergötland · Observational
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.
Research problems and specific questions Major depressive disorder (MDD) and stress induced exhaustion disorder (SED) are two growing public health concerns in primary care, causing individual suffering and affecting work productivity. MDD and SED call for different treatment strategies, but diagnosis differentiation pose several difficulties. Both conditions are linked to stress-related factors at work, and prescribed sick leave is a common treatment strategy. The main reasons for sick leave in DEP and UMS is cognitive difficulties, but no objective measures of cognition is used today. The aim of the PrimeCog project is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on cognitive function and underlying pathophysiology.
Data and method The project is a multicenter longitudinal, prospective research project on patients with newly diagnosed MDD or SED and healthy controls, n=100/group. The participants will be recruited at primary care centers. Data is collected through a digital cognitive test battery carried out at home, a questionnaire with screening scales and psychosocial risk factors, biomarkers in blood, saliva and hair, and a magnetic resonance imaging (MRI) of the brain. These procedures will be repeated after 12 and 24 months.
Societal relevance and utilization New diagnostic tools are needed for DEP and UMS in primary care to improve differential diagnosis and to individualize treatment in order to get the right intervention and treatment as quickly as possible. This could hypothetically contribute to shorter illness duration and reduce the length of sick leave. By investigating digital cognitive testing in primary care patients with MDD or SED, the PrimeCog project seeks to enhance diagnosis and follow-up which may prevent negative outcomes for individuals and benefit society by advancing mental health care as a whole. Digital cognitive testing is a new tool in primary care, and potentially both time- and cost-effective approach for objectively measuring cognitive symptoms.
130 studies on the registry are indexed under Neurobehavioral Manifestations; 27 are open to participants now.
This study's planned enrollment of 300 is above the median of 170 across 31 observational studies indexed under Neurobehavioral Manifestations.
Browse Neurobehavioral Manifestations studies →Region Östergötland is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients and controls in primary care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For the MRI subgroup, any to MRI is an exclusion criterion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals diagnosed with major depressive disorder (MDD)
Individuals diagnosed with stress induced exhaustion disorder (SED)
Diagnostic Test: Cognitive Testing
Healthy Controls (HC) (i.e. individuals without symptoms of MDD or SED)
Diagnostic Test: Cognitive Testing
Digital Cognitive Testing performed at home.
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)
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)
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)
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)
Cognitive Test Results regarding memory
How do cognitive test results regarding memory, measured by Corsi Span forward and backward, 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)
Cognitive Test Results regarding memory
How do cognitive test results regarding memory, measured by RAVLT Learning and Recall 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)
Cognitive Test Results regarding executive function
How do cognitive test results regarding executive functions, 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)
Cognitive Test Results regarding executive function
How do cognitive test results regarding executive functions, measured by Reaction Time Test Complex (or CPT) 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)
Cognitive Test Results regarding executive function
How do cognitive test results regarding executive functions, measured by Stroop Test 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)
Cognitive Test Results regarding language
How do cognitive test results regarding language, measured by FAS 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)
Cognitive Test Results regarding language
How do cognitive test results regarding language, measured by Boston Naming Test 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)
Cognitive Test Results regarding visuospatial capacity
How do cognitive test results regarding visuospatial capacity measured by: Cube Copying Test, 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)
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)
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)
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)
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)
Plan to share: Undecided — Probably upon request from mandated researchers, but yet to be decided.
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Started Apr 2024 (actual). Primary completion is estimated for Apr 2027, 36 months after the start.
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