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Trials / Completed

CompletedNCT03807167

Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Rennes University Hospital · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Accepted

Summary

Old age (\> 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. The investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with MDD. Having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with MDD and can be routinely used in a day-to-day medical practice.

Conditions

Interventions

TypeNameDescription
OTHERMattis Dementia Rating ScaleThis 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.
OTHERUnified Parkinson 's Disease Rating Scale-IIIThis 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.
OTHERMini Neuropsychiatric InvestigationThis 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.
OTHERMontgomery and Asberg depression Rating ScaleThis 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).
OTHERClinical Global Impressionheterosexual assessment that rates the severity of symptoms suicidal and changes in suicidal symptoms. Any subject with a score greater than 4 is not included.
OTHERApathy diagnostic criteriaThe 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.
OTHERwalking speed testThe patient is timed to walk 10m. A speed \<1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.
OTHERaccelerometer presentationaccelerometer presentation and pose
OTHERdata acquisition from the accelerometerwithdrawal of the accelerometer and data acquisition from the accelerometer
OTHERApathy 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.
OTHERfatigue Visual Analog ScaleTo 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.
OTHERexecutive 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.
OTHERMRIAn MRI lasting 30 minutes is programmed
OTHERApathy Motivation IndexThis 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".

Timeline

Start date
2019-08-09
Primary completion
2023-02-09
Completion
2023-02-09
First posted
2019-01-16
Last updated
2023-03-28

Locations

6 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03807167. Inclusion in this directory is not an endorsement.