search
Back to results

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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mattis Dementia Rating Scale
Unified Parkinson 's Disease Rating Scale-III
Mini Neuropsychiatric Investigation
Montgomery and Asberg depression Rating Scale
Clinical Global Impression
Apathy diagnostic criteria
walking speed test
accelerometer presentation
data acquisition from the accelerometer
Apathy Evaluation Scale,
fatigue Visual Analog Scale
executive function
MRI
Apathy Motivation Index
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Centre Mémoire de Ressources et de Recherche (CMRR),
  • CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale
  • Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte
  • CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie
  • CHU Bretonneau,CIC
  • Service de Radiologie- Neuroradiologie,CHU bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients

healthy controls

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

grey matter density
Magnetic Resonance Imaging brain metrics: grey matter density
cortical thickness
Magnetic Resonance Imaging brain metrics: cortical thickness;
diffusion tensor imaging,
Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,
Rest functional connectivity analysis
Magnetic Resonance Imaging brain metrics: regional cerebral blood flow
pulsatility.
Magnetic Resonance Imaging brain metrics: pulsatility.

Full Information

First Posted
December 7, 2018
Last Updated
March 27, 2023
Sponsor
Rennes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03807167
Brief Title
Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
Acronym
ACTIDEP
Official Title
Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Title
healthy controls
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mattis Dementia Rating Scale
Intervention Description
This scale was developed to assess the cognitive status of patients with neurodegenerative diseases. There are 37 items that are presented in a fixed order and grouped into five sub-scales: attention, initiation, construction, conceptualization and memory. Patients and healthy subjects with a score below 125 are not included because of major cognitive impairment.
Intervention Type
Other
Intervention Name(s)
Unified Parkinson 's Disease Rating Scale-III
Intervention Description
This scale is used to rate the severity of extra-pyramidal symptoms (akinesia, rigidity and tremors). These symptoms may be the cause of reduction of motor activity apart from any reduction in motivation, they onstitute a confounding factor that it should be controlled.
Intervention Type
Other
Intervention Name(s)
Mini Neuropsychiatric Investigation
Intervention Description
This is a structured interview that allows rapid screening in about 20 minutes of troubles Psychiatric. It is based on short questions to which the patient must answer yes or no and on a decision tree. Patients must validate clinical diagnoses of depression.
Intervention Type
Other
Intervention Name(s)
Montgomery and Asberg depression Rating Scale
Intervention Description
This scale is composed of 10 items from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum intensity of depression).
Intervention Type
Other
Intervention Name(s)
Clinical Global Impression
Intervention Description
heterosexual assessment that rates the severity of symptoms suicidal and changes in suicidal symptoms. Any subject with a score greater than 4 is not included.
Intervention Type
Other
Intervention Name(s)
Apathy diagnostic criteria
Intervention Description
The clinical criteria make it possible to make a diagnosis of apathy with a functional repercussion. It is based on a lack of motivation felt by the patient, causing a functional or social impact that is not the consequence of a disturbance of consciousness or a disability engine. The cognitive, emotional and behavioral dimensions are affected.
Intervention Type
Other
Intervention Name(s)
walking speed test
Intervention Description
The patient is timed to walk 10m. A speed <1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.
Intervention Type
Other
Intervention Name(s)
accelerometer presentation
Intervention Description
accelerometer presentation and pose
Intervention Type
Other
Intervention Name(s)
data acquisition from the accelerometer
Intervention Description
withdrawal of the accelerometer and data acquisition from the accelerometer
Intervention Type
Other
Intervention Name(s)
Apathy Evaluation Scale,
Intervention Description
clinician version and near-helping version. It's a hetero rating scale from an interview semi structured by a trained clinician. It assesses cognitive, emotional and behavioral apathy than three items of various apathy. The total score ranges from 18 (total absence of apathy) to 72.
Intervention Type
Other
Intervention Name(s)
fatigue Visual Analog Scale
Intervention Description
To date, there is no valid fatigue scale in the depression of the elderly subject, a fortiori in French. The fatigue scale in adult depression includes has been validated with an EVA (Visual Analogue Scale) (38). We therefore propose to use this type of evaluation to control this aspect.
Intervention Type
Other
Intervention Name(s)
executive function
Intervention Description
Modified Card Sorting Test MCST(Modified Card Sorting Test) (Wisconsin Test): This test assesses conceptualization, attention and mental flexibility using a deck of cards. Trail Making Test (TMT): This test is used to assess mental flexibility. Fluences verbal: This test tests the capacities of setting up search strategies in memory semantics and oral language. Stroop Paradigm: This test is used to evaluate the resistance to interference, ie the patient's ability to inhibit some over-learned and automated responses.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
An MRI lasting 30 minutes is programmed
Intervention Type
Other
Intervention Name(s)
Apathy Motivation Index
Intervention Description
This is a self-questionnaire of 18 items, each side on a 5-level Likert scale (0: not everything at 4: very often). It differentiates between "behavioral" apathy and "social" apathy. "Emotional".
Primary Outcome Measure Information:
Title
Actimetry
Description
Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer
Time Frame
3 days
Secondary Outcome Measure Information:
Title
grey matter density
Description
Magnetic Resonance Imaging brain metrics: grey matter density
Time Frame
at Day 3 (+/- 2 days)
Title
cortical thickness
Description
Magnetic Resonance Imaging brain metrics: cortical thickness;
Time Frame
at Day 3 (+/- 2 days)
Title
diffusion tensor imaging,
Description
Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,
Time Frame
at Day 3 (+/- 2 days)
Title
Rest functional connectivity analysis
Description
Magnetic Resonance Imaging brain metrics: regional cerebral blood flow
Time Frame
at Day 3 (+/- 2 days)
Title
pulsatility.
Description
Magnetic Resonance Imaging brain metrics: pulsatility.
Time Frame
at Day 3 (+/- 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centre Mémoire de Ressources et de Recherche (CMRR),
City
Nice
ZIP/Postal Code
06100
Country
France
Facility Name
CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte
City
Rennes
Country
France
Facility Name
CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Bretonneau,CIC
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Service de Radiologie- Neuroradiologie,CHU bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs