- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807167
Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging (ACTIDEP)
March 27, 2023 updated by: Rennes University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: Mattis Dementia Rating Scale
- Other: Unified Parkinson 's Disease Rating Scale-III
- Other: Mini Neuropsychiatric Investigation
- Other: Montgomery and Asberg depression Rating Scale
- Other: Clinical Global Impression
- Other: Apathy diagnostic criteria
- Other: walking speed test
- Other: accelerometer presentation
- Other: data acquisition from the accelerometer
- Other: Apathy Evaluation Scale,
- Other: fatigue Visual Analog Scale
- Other: executive function
- Other: MRI
- Other: Apathy Motivation Index
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gabriel Robert
- Phone Number: 02.99.33.39.37
- Email: gabriel.hadrien.robert@gmail.com
Study Locations
-
-
-
Nice, France, 06100
- Centre Mémoire de Ressources et de Recherche (CMRR),
-
Rennes, France, 35033
- CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale
-
Rennes, France
- Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte
-
Tours, France, 37044
- CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie
-
Tours, France, 37044
- CHU Bretonneau,CIC
-
Tours, France, 37044
- Service de Radiologie- Neuroradiologie,CHU bretonneau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients
|
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.
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.
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.
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).
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.
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.
The patient is timed to walk 10m.
A speed <1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.
accelerometer presentation and pose
withdrawal of the accelerometer and data acquisition from the accelerometer
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.
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.
An MRI lasting 30 minutes is programmed
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". |
Active Comparator: healthy controls
|
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.
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).
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.
accelerometer presentation and pose
withdrawal of the accelerometer and data acquisition from the accelerometer
An MRI lasting 30 minutes is programmed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actimetry
Time Frame: 3 days
|
Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
grey matter density
Time Frame: at Day 3 (+/- 2 days)
|
Magnetic Resonance Imaging brain metrics: grey matter density
|
at Day 3 (+/- 2 days)
|
cortical thickness
Time Frame: at Day 3 (+/- 2 days)
|
Magnetic Resonance Imaging brain metrics: cortical thickness;
|
at Day 3 (+/- 2 days)
|
diffusion tensor imaging,
Time Frame: at Day 3 (+/- 2 days)
|
Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,
|
at Day 3 (+/- 2 days)
|
Rest functional connectivity analysis
Time Frame: at Day 3 (+/- 2 days)
|
Magnetic Resonance Imaging brain metrics: regional cerebral blood flow
|
at Day 3 (+/- 2 days)
|
pulsatility.
Time Frame: at Day 3 (+/- 2 days)
|
Magnetic Resonance Imaging brain metrics: pulsatility.
|
at Day 3 (+/- 2 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2019
Primary Completion (Actual)
February 9, 2023
Study Completion (Actual)
February 9, 2023
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
January 15, 2019
First Posted (Actual)
January 16, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC18_8833_ACTIDEP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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