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

Not Applicable

Completed

• Conditions: Depression
• Interventions: 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: accelerometer presentation; Other: Clinical Global Impression; Other: data acquisition from the accelerometer; Other: Apathy diagnostic criteria; Other: executive function; Other: walking speed test; Other: MRI; Other: Apathy Evaluation Scale,; Other: fatigue Visual Analog Scale; Other: Apathy Motivation Index

• Registration Number: NCT03807167
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Study Start: 2019-08-09
• Primary Completion: 2023-02-09
• Study Completion: 2023-02-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Actimetry	3 days	Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer

Secondary Outcome Measures

Name	Time	Method
cortical thickness	at 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,
pulsatility.	at Day 3 (+/- 2 days)	Magnetic Resonance Imaging brain metrics: pulsatility.
grey matter density	at Day 3 (+/- 2 days)	Magnetic Resonance Imaging brain metrics: grey matter density
Rest functional connectivity analysis	at Day 3 (+/- 2 days)	Magnetic Resonance Imaging brain metrics: regional cerebral blood flow

Trial Locations

Locations (6)

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

Service de Radiologie- Neuroradiologie,CHU bretonneau; 🇫🇷 Tours, France

CHU Bretonneau,CIC; 🇫🇷 Tours, 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