Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
NCT ID: NCT03807167
Last Updated: 2023-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2019-08-09
2023-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients
Mattis Dementia Rating Scale
This scale was developed to assess the cognitive status of patients with neurodegenerative diseases. There are 37 items that are presented in a fixed order and grouped into five sub-scales: attention, initiation, construction, conceptualization and memory. Patients and healthy subjects with a score below 125 are not included because of major cognitive impairment.
Unified Parkinson 's Disease Rating Scale-III
This scale is used to rate the severity of extra-pyramidal symptoms (akinesia, rigidity and tremors). These symptoms may be the cause of reduction of motor activity apart from any reduction in motivation, they onstitute a confounding factor that it should be controlled.
Mini Neuropsychiatric Investigation
This is a structured interview that allows rapid screening in about 20 minutes of troubles Psychiatric. It is based on short questions to which the patient must answer yes or no and on a decision tree. Patients must validate clinical diagnoses of depression.
Montgomery and Asberg depression Rating Scale
This scale is composed of 10 items from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum intensity of depression).
Clinical Global Impression
heterosexual assessment that rates the severity of symptoms suicidal and changes in suicidal symptoms. Any subject with a score greater than 4 is not included.
Apathy diagnostic criteria
The clinical criteria make it possible to make a diagnosis of apathy with a functional repercussion. It is based on a lack of motivation felt by the patient, causing a functional or social impact that is not the consequence of a disturbance of consciousness or a disability engine. The cognitive, emotional and behavioral dimensions are affected.
walking speed test
The patient is timed to walk 10m. A speed \<1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.
accelerometer presentation
accelerometer presentation and pose
data acquisition from the accelerometer
withdrawal of the accelerometer and data acquisition from the accelerometer
Apathy Evaluation Scale,
clinician version and near-helping version. It's a hetero rating scale from an interview semi structured by a trained clinician. It assesses cognitive, emotional and behavioral apathy than three items of various apathy. The total score ranges from 18 (total absence of apathy) to 72.
fatigue Visual Analog Scale
To date, there is no valid fatigue scale in the depression of the elderly subject, a fortiori in French. The fatigue scale in adult depression includes has been validated with an EVA (Visual Analogue Scale) (38). We therefore propose to use this type of evaluation to control this aspect.
executive function
* Modified Card Sorting Test MCST(Modified Card Sorting Test) (Wisconsin Test): This test assesses conceptualization, attention and mental flexibility using a deck of cards.
* Trail Making Test (TMT): This test is used to assess mental flexibility.
* Fluences verbal: This test tests the capacities of setting up search strategies in memory semantics and oral language.
* Stroop Paradigm: This test is used to evaluate the resistance to interference, ie the patient's ability to inhibit some over-learned and automated responses.
MRI
An MRI lasting 30 minutes is programmed
Apathy Motivation Index
This is a self-questionnaire of 18 items, each side on a 5-level Likert scale (0: not everything at 4: very often). It differentiates between "behavioral" apathy and "social" apathy.
"Emotional".
healthy controls
Mini Neuropsychiatric Investigation
This is a structured interview that allows rapid screening in about 20 minutes of troubles Psychiatric. It is based on short questions to which the patient must answer yes or no and on a decision tree. Patients must validate clinical diagnoses of depression.
Montgomery and Asberg depression Rating Scale
This scale is composed of 10 items from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum intensity of depression).
Clinical Global Impression
heterosexual assessment that rates the severity of symptoms suicidal and changes in suicidal symptoms. Any subject with a score greater than 4 is not included.
accelerometer presentation
accelerometer presentation and pose
data acquisition from the accelerometer
withdrawal of the accelerometer and data acquisition from the accelerometer
executive function
* Modified Card Sorting Test MCST(Modified Card Sorting Test) (Wisconsin Test): This test assesses conceptualization, attention and mental flexibility using a deck of cards.
* Trail Making Test (TMT): This test is used to assess mental flexibility.
* Fluences verbal: This test tests the capacities of setting up search strategies in memory semantics and oral language.
* Stroop Paradigm: This test is used to evaluate the resistance to interference, ie the patient's ability to inhibit some over-learned and automated responses.
MRI
An MRI lasting 30 minutes is programmed
Interventions
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Mattis Dementia Rating Scale
This scale was developed to assess the cognitive status of patients with neurodegenerative diseases. There are 37 items that are presented in a fixed order and grouped into five sub-scales: attention, initiation, construction, conceptualization and memory. Patients and healthy subjects with a score below 125 are not included because of major cognitive impairment.
Unified Parkinson 's Disease Rating Scale-III
This scale is used to rate the severity of extra-pyramidal symptoms (akinesia, rigidity and tremors). These symptoms may be the cause of reduction of motor activity apart from any reduction in motivation, they onstitute a confounding factor that it should be controlled.
Mini Neuropsychiatric Investigation
This is a structured interview that allows rapid screening in about 20 minutes of troubles Psychiatric. It is based on short questions to which the patient must answer yes or no and on a decision tree. Patients must validate clinical diagnoses of depression.
Montgomery and Asberg depression Rating Scale
This scale is composed of 10 items from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum intensity of depression).
Clinical Global Impression
heterosexual assessment that rates the severity of symptoms suicidal and changes in suicidal symptoms. Any subject with a score greater than 4 is not included.
Apathy diagnostic criteria
The clinical criteria make it possible to make a diagnosis of apathy with a functional repercussion. It is based on a lack of motivation felt by the patient, causing a functional or social impact that is not the consequence of a disturbance of consciousness or a disability engine. The cognitive, emotional and behavioral dimensions are affected.
walking speed test
The patient is timed to walk 10m. A speed \<1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.
accelerometer presentation
accelerometer presentation and pose
data acquisition from the accelerometer
withdrawal of the accelerometer and data acquisition from the accelerometer
Apathy Evaluation Scale,
clinician version and near-helping version. It's a hetero rating scale from an interview semi structured by a trained clinician. It assesses cognitive, emotional and behavioral apathy than three items of various apathy. The total score ranges from 18 (total absence of apathy) to 72.
fatigue Visual Analog Scale
To date, there is no valid fatigue scale in the depression of the elderly subject, a fortiori in French. The fatigue scale in adult depression includes has been validated with an EVA (Visual Analogue Scale) (38). We therefore propose to use this type of evaluation to control this aspect.
executive function
* Modified Card Sorting Test MCST(Modified Card Sorting Test) (Wisconsin Test): This test assesses conceptualization, attention and mental flexibility using a deck of cards.
* Trail Making Test (TMT): This test is used to assess mental flexibility.
* Fluences verbal: This test tests the capacities of setting up search strategies in memory semantics and oral language.
* Stroop Paradigm: This test is used to evaluate the resistance to interference, ie the patient's ability to inhibit some over-learned and automated responses.
MRI
An MRI lasting 30 minutes is programmed
Apathy Motivation Index
This is a self-questionnaire of 18 items, each side on a 5-level Likert scale (0: not everything at 4: very often). It differentiates between "behavioral" apathy and "social" apathy.
"Emotional".
Eligibility Criteria
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Inclusion Criteria
* 60 years and above
* Major depressive disorder (either late-onset or early onset)
* Ambulatory settings
* Both uni and bipolar depression will be considered Healthy controls
* 60 years and above
* No psychiatric disorders, including no major depressive disorder
Exclusion Criteria
* Major cognitive disorders (\< 125 on the Mattis dementia rating scale and a major cognitive disorders diagnostic according to the DSM5 (Diagnostic and Statistical Manual of Mental Disorders) criteria).
* Other neurological conditions (stroke, Parkinson's disease and seizures), severe and inflammatory disorders (ex: severe arthroses which limits movements, spondylarthritis)
* Severe sarcopenia: speed walk \< 1 meter/second
* Extrapyramidal syndrome
* High suicidal risk
* Anti-psychotic prescription
* Participant who are unable to provide clear consent, under legal protection
* MRI contra-indication
60 Years
ALL
Yes
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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Centre Mémoire de Ressources et de Recherche (CMRR),
Nice, , France
CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale
Rennes, , France
Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte
Rennes, , France
CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie
Tours, , France
CHU Bretonneau,CIC
Tours, , France
Service de Radiologie- Neuroradiologie,CHU bretonneau
Tours, , France
Countries
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Other Identifiers
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35RC18_8833_ACTIDEP
Identifier Type: -
Identifier Source: org_study_id
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