PrimeCog: Primary Care Cognitive Testing

NCT06346535 | Recruiting

• 1 other identifier: 2022-05703-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Mental Health Issue; Cognitive Symptom; Primary Health Care

Outcome Measures

Primary Outcomes (12)

• 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?

  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?

  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?

  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?

  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?

  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?

  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?

  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?

  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?

  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?

  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?

  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?

  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)

• MRI features, measured by morphological and quantitative MR sequences of the brain

  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

  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

  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

  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)

Study Arms (3)

Case1

Individuals diagnosed with major depressive disorder (MDD)

Case2

Individuals diagnosed with stress induced exhaustion disorder (SED)

Diagnostic Test: Cognitive Testing

Control

Healthy Controls (HC) (i.e. individuals without symptoms of MDD or SED)

Diagnostic Test: Cognitive Testing

Interventions

Cognitive Testing DIAGNOSTIC_TEST

Digital Cognitive Testing performed at home.

Case2; Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients and controls in primary care.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Östergötland: lead

Study Sites (1)

Region Ostergotland, primary care centrum

Linköping, Östergötland County, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva.

MeSH Terms

Conditions

Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanna Israelsson Larsen, PhD

  Region Ostergotland/Linkoping University

  PRINCIPAL INVESTIGATOR

• Anna Segernas, PhD

  Region Ostergotland/Linkoping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Israelssion Larsen, PhD

CONTACT

+46738317008; hanna.israelsson.larsen@regionostergotland.se

Anna Segernäs, PhD

CONTACT

+46733641430; anna.segernas@liu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

SE (1)