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Completed

NCT Number: NCT05523076

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

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Key information

Conditions

Major Depressive Disorder BDMF Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major GSH Mental Disorders Mood Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

About this study

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

  • Patients will show an objective cognitive deficit with both subjective and objective measures compared to healthy controls.
  • 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.
  • 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.
  • Cognitive Reserve will be a mediating factor in the correlation between subjective and objective cognitive evaluation.
  • 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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cognitive outcome

    Time frame: 1 assessment

    Composite score of different neuropsychological tests

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Fundacion Clinic per a la Recerca Biomédica
  • Institut de Recerca Biomèdica de Lleida

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 31, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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