Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807167
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Depression 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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients Other: Mattis Dementia Rating Scale
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.

Other: Unified Parkinson 's Disease Rating Scale-III
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.

Other: Mini Neuropsychiatric Investigation
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.

Other: Montgomery and Asberg depression Rating Scale
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).

Other: Clinical Global Impression
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.

Other: Apathy diagnostic criteria
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.

Other: walking speed test
The patient is timed to walk 10m. A speed <1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.

Other: accelerometer presentation
accelerometer presentation and pose

Other: data acquisition from the accelerometer
withdrawal of the accelerometer and data acquisition from the accelerometer

Other: Apathy Evaluation Scale,
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.

Other: fatigue Visual Analog Scale
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.

Other: executive function
  • 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.

Other: MRI
An MRI lasting 30 minutes is programmed

Active Comparator: healthy controls Other: Mini Neuropsychiatric Investigation
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.

Other: Montgomery and Asberg depression Rating Scale
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).

Other: Clinical Global Impression
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.

Other: accelerometer presentation
accelerometer presentation and pose

Other: data acquisition from the accelerometer
withdrawal of the accelerometer and data acquisition from the accelerometer

Other: executive function
  • 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.

Other: MRI
An MRI lasting 30 minutes is programmed




Primary Outcome Measures :
  1. Actimetry [ Time Frame: 3 days ]
    Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer


Secondary Outcome Measures :
  1. grey matter density [ Time Frame: at Day 3 ]
    Magnetic Resonance Imaging brain metrics: grey matter density

  2. cortical thickness [ Time Frame: at Day 3 ]
    Magnetic Resonance Imaging brain metrics: cortical thickness;

  3. diffusion tensor imaging, [ Time Frame: at Day 3 ]
    Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,

  4. regional cerebral blood flow [ Time Frame: at Day 3 ]
    Magnetic Resonance Imaging brain metrics: regional cerebral blood flow

  5. pulsatility. [ Time Frame: at Day 3 ]
    Magnetic Resonance Imaging brain metrics: pulsatility.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807167


Contacts
Layout table for location contacts
Contact: Gabriel Robert 02.99.33.39.37 gabriel.hadrien.robert@gmail.com

Locations
Layout table for location information
France
Centre Mémoire de Ressources et de Recherche (CMRR), Not yet recruiting
Nice, France, 06100
Contact: Renaud David         
Principal Investigator: Renaud David         
CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale Not yet recruiting
Rennes, France, 35033
Contact: Jean-Christophe FERRE         
Principal Investigator: Jean-Christophe FERRE         
Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte Not yet recruiting
Rennes, France
Contact: Gabriel Robert    02.99.33.39.37    gabriel.hadrien.robert@gmail.com   
Principal Investigator: Gabriel Robert         
CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie Not yet recruiting
Tours, France, 37044
Contact: Thomas DESMIDT    02 34 37 89 52      
Principal Investigator: Thomas DESMIDT         
CHU Bretonneau,CIC Not yet recruiting
Tours, France, 37044
Contact: Valérie Gissot         
Principal Investigator: Valérie Gissot         
Service de Radiologie- Neuroradiologie,CHU bretonneau Not yet recruiting
Tours, France, 37044
Contact: Jean-Philippe Cottier         
Principal Investigator: Jean-Philippe Cottier         
Sponsors and Collaborators
Rennes University Hospital

Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03807167     History of Changes
Other Study ID Numbers: 35RC18_8833_ACTIDEP
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders