Transdiagnostic Markers of Cognitive Symptoms in Disorders Affective.

NCT05523076 | Completed DMC

• 1 other identifier: IIBSP-AFE-2018-10
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder; Bipolar Disorder; BDMF; GSH; Neurologic Manifestations

Outcome Measures

Primary Outcomes (1)

• Cognitive outcome

  Composite score of different neuropsychological tests

  1 assessment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling of peripheral inflammatory markers.

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Research Group in Psychiatric Disorders, Hospital de Sant Pau

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: August 31, 2022
• Study Start: March 15, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2021
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

ES (1)