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Clinical Trials/NCT03807167
NCT03807167
Completed
Not Applicable

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

Rennes University Hospital6 sites in 1 country102 target enrollmentAugust 9, 2019
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Rennes University Hospital
Enrollment
102
Locations
6
Primary Endpoint
Actimetry
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2019
End Date
February 9, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Actimetry

Time Frame: 3 days

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

Secondary Outcomes

  • cortical thickness(at Day 3 (+/- 2 days))
  • diffusion tensor imaging,(at Day 3 (+/- 2 days))
  • pulsatility.(at Day 3 (+/- 2 days))
  • grey matter density(at Day 3 (+/- 2 days))
  • Rest functional connectivity analysis(at Day 3 (+/- 2 days))

Study Sites (6)

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