Clinical trial NCT03807167: Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
Official title: Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Actimetry
timeFrame: 3 days
Secondary outcomes:
measure: grey matter density
timeFrame: at Day 3 (+/- 2 days)
measure: cortical thickness
timeFrame: at Day 3 (+/- 2 days)
measure: diffusion tensor imaging,
timeFrame: at Day 3 (+/- 2 days)
measure: Rest functional connectivity analysis
timeFrame: at Day 3 (+/- 2 days)
measure: pulsatility.
timeFrame: at Day 3 (+/- 2 days)
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Mémoire de Ressources et de Recherche (CMRR),
city: Rennes
country: France
facility: CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale
city: Rennes
country: France
facility: Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte
city: Tours
country: France
facility: CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie
city: Tours
country: France
facility: CHU Bretonneau,CIC
city: Tours
country: France
facility: Service de Radiologie- Neuroradiologie,CHU bretonneau
Study officials:
References: