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Completed

NCT Number: NCT03807167

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Mémoire de Ressources et de Recherche (CMRR),, Nice, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mattis Dementia Rating Scale

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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

Other

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

Other

accelerometer presentation and pose

data acquisition from the accelerometer

Other

withdrawal of the accelerometer and data acquisition from the accelerometer

Apathy Evaluation Scale,

Other

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

Other

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

Other
  • 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

Other

An MRI lasting 30 minutes is programmed

Apathy Motivation Index

Other

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".

Primary outcomes

  1. Actimetry

    Time frame: 3 days

    Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer

Secondary outcomes

  1. grey matter density

    Time frame: at Day 3 (+/- 2 days)

    Magnetic Resonance Imaging brain metrics: grey matter density

  2. cortical thickness

    Time frame: at Day 3 (+/- 2 days)

    Magnetic Resonance Imaging brain metrics: cortical thickness;

  3. diffusion tensor imaging,

    Time frame: at Day 3 (+/- 2 days)

    Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,

  4. Rest functional connectivity analysis

    Time frame: at Day 3 (+/- 2 days)

    Magnetic Resonance Imaging brain metrics: regional cerebral blood flow

  5. pulsatility.

    Time frame: at Day 3 (+/- 2 days)

    Magnetic Resonance Imaging brain metrics: pulsatility.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ACTIDEP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 16, 2019
Registry last updated
Mar 28, 2023

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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