Transdiagnostic Markers of Cognitive Symptoms in Disorders Affective.

The objective of this project is to determine the concordance between the subjective and objective evaluation of cognitive functions in affective patients in partial remission through scales and cognitive tests that would be easily implemented in the different mental health care devices.

This is a cross-sectional case-control study of non-probabilistic sampling, which will include a group of patients diagnosed with Major Depressive Disorder and Bipolar Disorder and a group of healthy controls from the same population and matched by age, gender and years of education with the group of patients.

Patients will be recruited from the psychiatric service of the Hospital de la Santa Creu i Sant Pau who meet the inclusion criteria, and they will undergo a blood draw, a clinical assessment, a complete neuropsychological examination together with scales of subjective perception of cognitive deficit, a measure of cognitive reserve and an evaluation of psychosocial functionality. In addition, the same evaluation will be made to a group of healthy subjects.The total sample will be 120

Study Overview

• Status: Completed
• Conditions: Neurologic Manifestations; Bipolar Disorder; Major Depressive Disorder; BDMF; GSH

Detailed Description

This is a cross-sectional study with the following hypotheses and objectives:

1. Patients will show an objective cognitive deficit with both subjective and objective measures compared to healthy controls.
2. Subjectively and objectively assessed cognitive deficits will show moderate agreement in patients with a depressive episode in partial remission, as each assesses different aspects of cognition.
3. Both the subjective and the objective assessment will have a high agreement between patients with DM and TB, demonstrating the transdiagnostic nature of self-assessed and heteroassessed cognitive deficits.
4. Cognitive Reserve will be a mediating factor in the correlation between subjective and objective cognitive evaluation.
5. BDNF and GSH will be associated with the patients' cognitive deficit and will act as mediators between the subjective and objective assessment.

Main Objective:

To study the impact of cognitive reserve and trophic factors and oxidative stress as transdiagnostic markers of cognitive symptoms (subjective and objective) in patients with DM and TB.

1. Cognitively assess patients with DM and TB (in a depressive episode) through subjective assessment and objective assessment.
2. Evaluate the possible implementation of objective (SCIP) and subjective (COBRA, PDQ) cognitive assessment instruments.
3. Determine the degree of agreement between both types of cognitive assessment both intra-patient and inter-diagnostic.
4. Determine the factors associated with the degree of agreement between both assessments (Cognitive Reserve, BDNF and GSH) in and between both affective disorders.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients with major depressive disorder and bipolar disorder. In addition, a control group with healthy subjects matched by age, educational level and sex will be included.

Description

Inclusion Criteria:

• 8 and 60 years (males and females)
• diagnosis of Major Depression (criteria Diagnostic and Statistical Manual 5th edition, DSM-5) in Remission or Partial Remission phase (scores below 14 in the Hamilton Depression Rating Scale-17 items (HDRS-17))
• Cognitive Symptoms (-1.5SD (standar deviation) in objective as subjective tests)
• PDQ > 20
• FAST> 17

Exclusion Criteria:

• Intelligence Quotient (IQ) < 85
• Any medical condition that may affect cognition
• Presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months)
• Electroconvulsive therapy (ECT) in the previous year
• Other psychological intervention in the 6 months prior to the study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive outcome	Composite score of different neuropsychological tests	1 assessment

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Fundacion Clinic per a la Recerca Biomédica; Institut de Recerca Biomèdica de Lleida

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Bipolar and Related Disorders; Depressive Disorder; Disease; Bipolar Disorder; Depressive Disorder, Major; Neurobehavioral Manifestations; Neurologic Manifestations
• Other Study ID Numbers: IIBSP-AFE-2018-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No