Major Depressive DisorderNCT05523076
Transdiagnostic Markers of Cognitive Symptoms in Disorders Affective.
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, BDMF
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive outcome
Composite score of different neuropsychological tests
Measured: 1 assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Mar 2018
- Primary completion30 Jun 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica, Institut de Recerca Biomèdica de Lleida
- Responsible party
- Principal investigator, Maria J Portella, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523076
- Sponsor's protocol ID
- IIBSP-AFE-2018-10
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Markers of Cognitive Symptoms in Disorders Affective.
- ClinicalTrials.gov ID
- NCT05523076
- Acronym / sponsor ID
- IIBSP-AFE-2018-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fundacion Clinic per a la Recerca Biomédica, Institut de Recerca Biomèdica de Lleida
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive outcome
Time frame: 1 assessment
Composite score of different neuropsychological tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive outcome (time frame: 1 assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.