DepressionACTIDEPNCT03807167
Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
A study testing Mattis Dementia Rating Scale, Unified Parkinson 's Disease Rating Scale-III and Mini Neuropsychiatric Investigation in people with Depression, run by Rennes University Hospital at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Mattis Dementia Rating Scale, Unified Parkinson 's Disease Rating Scale-III and Mini Neuropsychiatric Investigation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 6 sitesFrance
- Study dates
- 9 Aug 2019to 9 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Anti-psychotic prescription
- Participant who are unable to provide clear consent, under legal protection
- MRI contra-indication
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Mémoire de Ressources et de Recherche (CMRR),
Nice, 06100
CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale
Rennes, 35033
Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte
Rennes
CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie
Tours, 37044
CHU Bretonneau,CIC
Tours, 37044
Service de Radiologie- Neuroradiologie,CHU bretonneau
Tours, 37044
About this study
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.
- Conditions
- Depression
- Being tested
- Mattis Dementia Rating Scale, Unified Parkinson 's Disease Rating Scale-III, Mini Neuropsychiatric Investigation, Montgomery and Asberg depression Rating Scale, Clinical Global Impression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mattis Dementia Rating ScaleOther
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.
Unified Parkinson 's Disease Rating Scale-IIIOther
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.
Mini Neuropsychiatric InvestigationOther
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.
Montgomery and Asberg depression Rating ScaleOther
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).
Clinical Global ImpressionOther
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.
Apathy diagnostic criteriaOther
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.
walking speed testOther
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 presentationOther
accelerometer presentation and pose
data acquisition from the accelerometerOther
withdrawal of the accelerometer and data acquisition from the accelerometer
Apathy Evaluation Scale,Other
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.
fatigue Visual Analog ScaleOther
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.
executive functionOther
- 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.
MRIOther
An MRI lasting 30 minutes is programmed
Apathy Motivation IndexOther
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".
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: 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 |
| healthy controls | Active comparator | Not described Receives: Other: Mini Neuropsychiatric Investigation; Other: Montgomery and Asberg depression Rating Scale; Other: Clinical Global Impression; Other: accelerometer presentation; Other: data acquisition from the accelerometer; Other: executive function; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actimetry
Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer
Measured: 3 days
Secondary outcomes (5)
grey matter density
Magnetic Resonance Imaging brain metrics: grey matter density
Measured: at Day 3 (+/- 2 days)
cortical thickness
Magnetic Resonance Imaging brain metrics: cortical thickness;
Measured: at Day 3 (+/- 2 days)
diffusion tensor imaging,
Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,
Measured: at Day 3 (+/- 2 days)
Rest functional connectivity analysis
Magnetic Resonance Imaging brain metrics: regional cerebral blood flow
Measured: at Day 3 (+/- 2 days)
pulsatility.
Magnetic Resonance Imaging brain metrics: pulsatility.
Measured: at Day 3 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start9 Aug 2019
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807167
- Sponsor's protocol ID
- 35RC18_8833_ACTIDEP
- Acronym
- ACTIDEP
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2018
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03807167
- Acronym / sponsor ID
- ACTIDEP / 35RC18_8833_ACTIDEP
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | 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 |
| healthy controls | Active comparator | Other: Mini Neuropsychiatric Investigation, Other: Montgomery and Asberg depression Rating Scale, Other: Clinical Global Impression, Other: accelerometer presentation, Other: data acquisition from the accelerometer, Other: executive function, Other: MRI |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mattis Dementia Rating ScaleThis 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 | Patients |
| Unified Parkinson 's Disease Rating Scale-IIIThis 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 | Patients |
| Mini Neuropsychiatric InvestigationThis 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 | Patients, healthy controls |
| Montgomery and Asberg depression Rating ScaleThis 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 | Patients, healthy controls |
| Clinical Global Impressionheterosexual 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 | Patients, healthy controls |
| Apathy diagnostic criteriaThe 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 | Patients |
| walking speed testThe patient is timed to walk 10m. A speed <1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias. | Other | Patients |
| accelerometer presentationaccelerometer presentation and pose | Other | Patients, healthy controls |
| data acquisition from the accelerometerwithdrawal of the accelerometer and data acquisition from the accelerometer | Other | Patients, healthy controls |
| 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 | Patients |
| fatigue Visual Analog ScaleTo 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 | Patients |
| 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 | Patients, healthy controls |
| MRIAn MRI lasting 30 minutes is programmed | Other | Patients, healthy controls |
| Apathy Motivation IndexThis 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". | Other | Patients |
Primary outcome
Actimetry
Time frame: 3 days
Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer
5 secondary outcomes
grey matter density
Time frame: at Day 3 (+/- 2 days)
cortical thickness
Time frame: at Day 3 (+/- 2 days)
diffusion tensor imaging,
Time frame: at Day 3 (+/- 2 days)
Rest functional connectivity analysis
Time frame: at Day 3 (+/- 2 days)
pulsatility.
Time frame: at Day 3 (+/- 2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mattis Dementia Rating Scale, Unified Parkinson 's Disease Rating Scale-III and Mini Neuropsychiatric Investigation in people with Depression, run by Rennes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actimetry (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.