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

NCT03807167 | Completed

• 1 other identifier: 35RC18_8833_ACTIDEP
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Actimetry

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

  3 days

Secondary Outcomes (5)

• grey matter density

  at Day 3 (+/- 2 days)

• cortical thickness

  at Day 3 (+/- 2 days)

• diffusion tensor imaging,

  at Day 3 (+/- 2 days)

• Rest functional connectivity analysis

  at Day 3 (+/- 2 days)

• pulsatility.

  at Day 3 (+/- 2 days)

Study Arms (2)

Patients

EXPERIMENTAL

Other: Mattis Dementia Rating Scale; Other: Unified Parkinson 's Disease Rating Scale-III; Other: Mini Neuropsychiatric Investigation; Other: Montgomery and Asberg depression Rating Scale; Other: Clinical Global Impression; Other: Apathy diagnostic criteria; Other: walking speed test; Other: accelerometer presentation; Other: data acquisition from the accelerometer; Other: Apathy Evaluation Scale,; Other: fatigue Visual Analog Scale; Other: executive function; Other: MRI; Other: Apathy Motivation Index

healthy controls

ACTIVE COMPARATOR

Other: Mini Neuropsychiatric Investigation; Other: Montgomery and Asberg depression Rating Scale; Other: Clinical Global Impression; Other: accelerometer presentation; Other: data acquisition from the accelerometer; Other: executive function; Other: MRI

Interventions

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.

Patients

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.

Patients

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.

Patients; healthy controls

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).

Patients; healthy controls

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.

Patients; healthy controls

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.

Patients

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.

Patients

accelerometer presentation OTHER

accelerometer presentation and pose

Patients; healthy controls

data acquisition from the accelerometer OTHER

withdrawal of the accelerometer and data acquisition from the accelerometer

Patients; healthy controls

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.

Patients

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.

Patients

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.

Patients; healthy controls

MRI OTHER

An MRI lasting 30 minutes is programmed

Patients; healthy controls

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".

Patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• years and above
• Major depressive disorder (either late-onset or early onset)
• Ambulatory settings
• Both uni and bipolar depression will be considered Healthy controls
• years and above
• No psychiatric disorders, including no major depressive disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (6)

Centre Mémoire de Ressources et de Recherche (CMRR),

Nice, 06100, France

Location

CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale

Rennes, 35033, France

Location

Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte

Rennes, France

Location

CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie

Tours, 37044, France

Location

CHU Bretonneau,CIC

Tours, 37044, France

Location

Service de Radiologie- Neuroradiologie,CHU bretonneau

Tours, 37044, France

Location

MeSH Terms

Conditions

Depression

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: January 16, 2019
• Study Start: August 9, 2019
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

FR (6)