Major Depressive Disorder Clinical Trial
Official title:
Transdiagnostic Markers of Cognitive Symptoms in Disorders Affective.
Verified date | August 2022 |
Source | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 105 |
Est. completion date | December 31, 2021 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Fundacion Clinic per a la Recerca Biomédica, Institut de Recerca Biomèdica de Lleida |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive outcome | Composite score of different neuropsychological tests | 1 assessment |
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