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

Rennes University Hospital

Status: Completed

Conditions: Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03807167

35RC18_8833_ACTIDEP

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Patients

Experimental group

Treatment:

Other: MRI

Other: executive function

Other: Clinical Global Impression

Other: fatigue Visual Analog Scale

Other: accelerometer presentation

Other: Apathy Evaluation Scale,

Other: data acquisition from the accelerometer

Other: Mini Neuropsychiatric Investigation

Other: Apathy diagnostic criteria

Other: Montgomery and Asberg depression Rating Scale

Other: Mattis Dementia Rating Scale

Other: Apathy Motivation Index

Other: walking speed test

Other: Unified Parkinson 's Disease Rating Scale-III

healthy controls

Active Comparator group

Treatment:

Other: MRI

Other: executive function

Other: Clinical Global Impression

Other: accelerometer presentation

Other: data acquisition from the accelerometer

Other: Mini Neuropsychiatric Investigation

Other: Montgomery and Asberg depression Rating Scale