AzTrials
AzTrials

Mental Health IssuePrimeCogNCT06346535

PrimeCog: Primary Care Cognitive Testing

An observational study of Mental Health Issue and Cognitive Symptom, run by Region Östergötland at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Cognitive Testing
How many people
300 participants
Where
1 siteSweden
Study dates
1 Apr 2024to 1 Apr 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients and controls in primary care.

Who may be able to join

  • 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)

Who cannot join

  • 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;
  • substance dependence, ongoing or past;
  • motor disability or impairment affecting interaction with the digital tests;
  • photosensitive epilepsy or -migraines.
  • For the MRI subgroup, any contraindication to MRI is an exclusion criterion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Segernäs, PhD contact

+46733641430

anna.segernas@liu.se

Sweden1 site, 1 recruiting
  • Region Ostergotland, primary care centrum

    Linköping, Östergötland County

    Hanna Israelsson Larsen, PhD, 0738317008, hanna.israelsson.larsen@regionostergotland.se

    Anna Segernas, PhD, +46733641430, anna.segernas@liu.se

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

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.

Read the detailed description

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.

Being tested
Cognitive Testing
Medical subject headings
Neurobehavioral Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TestingDiagnostic test

    Digital Cognitive Testing performed at home.

Study groups in NCT06346535
Study groupRoleWhat they receive
Case1Individuals diagnosed with major depressive disorder (MDD)
Case2Individuals diagnosed with stress induced exhaustion disorder (SED)
Receives: Diagnostic Test: Cognitive Testing
ControlHealthy Controls (HC) (i.e. individuals without symptoms of MDD or SED)
Receives: Diagnostic Test: Cognitive Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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?

    Measured: 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?

    Measured: 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?

    Measured: 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?

    Measured: 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)

  5. 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?

    Measured: 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)

  6. 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?

    Measured: 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)

  7. 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?

    Measured: 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)

  8. 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?

    Measured: 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)

  9. 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?

    Measured: 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)

  10. Cognitive Test Results regarding language

    How do cognitive test results regarding language, measured by FAS vary between individuals with MDD/SED and HC?

    Measured: 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)

  11. 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?

    Measured: 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)

  12. 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?

    Measured: 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 (4)
  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?

    Measured: 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?

    Measured: 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?

    Measured: 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?

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06346535
Sponsor's protocol ID
2022-05703-01
Acronym
PrimeCog
Status last verified
Apr 2024
First submitted
6 Mar 2024
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Probably upon request from mandated researchers, but yet to be decided.

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Issue and Cognitive Symptom, run by Region Östergötland at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hanna Israelssion Larsen, PhD (+46738317008, hanna.israelsson.larsen@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Test Results regarding attention and processing speed (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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in