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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03807167
Acronym
ACTIDEP
Enrollment
102
Registered
2019-01-16
Start date
2019-08-09
Completion date
2023-02-09
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief 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.

Interventions

OTHERMattis 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.

OTHERUnified 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.

OTHERMini 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.

OTHERMontgomery 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).

OTHERClinical 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.

OTHERApathy 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.

OTHERwalking 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.

OTHERaccelerometer presentation

accelerometer presentation and pose

OTHERdata acquisition from the accelerometer

withdrawal 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 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.

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.

OTHERMRI

An MRI lasting 30 minutes is programmed

OTHERApathy 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.

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Patients: * 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 * No non-inclusion criteria

Exclusion criteria

* Patients and healthy controls * 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

Design outcomes

Primary

MeasureTime frameDescription
Actimetry3 daysMeasure of actimetry: immobility, transfer, walking, movement given by the accelerometer

Secondary

MeasureTime frameDescription
grey matter densityat Day 3 (+/- 2 days)Magnetic Resonance Imaging brain metrics: grey matter density
cortical thicknessat Day 3 (+/- 2 days)Magnetic Resonance Imaging brain metrics: cortical thickness;
diffusion tensor imaging,at Day 3 (+/- 2 days)Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,
Rest functional connectivity analysisat Day 3 (+/- 2 days)Magnetic Resonance Imaging brain metrics: regional cerebral blood flow
pulsatility.at Day 3 (+/- 2 days)Magnetic Resonance Imaging brain metrics: pulsatility.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026