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

Not Applicable

Completed

• Conditions: Depression

• 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

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

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

CHU Bretonneau,CIC; 🇫🇷 Tours, France

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