<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03807167</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_8833_ACTIDEP</org_study_id>
    <nct_id>NCT03807167</nct_id>
  </id_info>
  <brief_title>Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging</brief_title>
  <acronym>ACTIDEP</acronym>
  <official_title>Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Old age (&gt; 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles&#xD;
      the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of&#xD;
      motivation) is a core problem in depression in older age and is frequently associated with&#xD;
      cognitive decline in people who have mild cognitive disorders. The investigator propose here&#xD;
      to combine actimetry (the measurement of motor activity using a simple device worn at the&#xD;
      wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a&#xD;
      population of elders with MDD. Having shown that apathy can reliably be measured with&#xD;
      actimetry and that it is associated with brain abnormalities, the investigator will be able&#xD;
      to test whether actimetry can predict cognitive decline in elders with MDD and can be&#xD;
      routinely used in a day-to-day medical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2019</start_date>
  <completion_date type="Actual">February 9, 2023</completion_date>
  <primary_completion_date type="Actual">February 9, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Actimetry</measure>
    <time_frame>3 days</time_frame>
    <description>Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>grey matter density</measure>
    <time_frame>at Day 3 (+/- 2 days)</time_frame>
    <description>Magnetic Resonance Imaging brain metrics: grey matter density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cortical thickness</measure>
    <time_frame>at Day 3 (+/- 2 days)</time_frame>
    <description>Magnetic Resonance Imaging brain metrics: cortical thickness;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diffusion tensor imaging,</measure>
    <time_frame>at Day 3 (+/- 2 days)</time_frame>
    <description>Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rest functional connectivity analysis</measure>
    <time_frame>at Day 3 (+/- 2 days)</time_frame>
    <description>Magnetic Resonance Imaging brain metrics: regional cerebral blood flow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulsatility.</measure>
    <time_frame>at Day 3 (+/- 2 days)</time_frame>
    <description>Magnetic Resonance Imaging brain metrics: pulsatility.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mattis Dementia Rating Scale</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unified Parkinson 's Disease Rating Scale-III</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mini Neuropsychiatric Investigation</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Montgomery and Asberg depression Rating Scale</intervention_name>
    <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).</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Global Impression</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apathy diagnostic criteria</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>walking speed test</intervention_name>
    <description>The patient is timed to walk 10m. A speed &lt;1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>accelerometer presentation</intervention_name>
    <description>accelerometer presentation and pose</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data acquisition from the accelerometer</intervention_name>
    <description>withdrawal of the accelerometer and data acquisition from the accelerometer</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apathy Evaluation Scale,</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fatigue Visual Analog Scale</intervention_name>
    <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.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>executive function</intervention_name>
    <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.&#xD;
Trail Making Test (TMT): This test is used to assess mental flexibility.&#xD;
Fluences verbal: This test tests the capacities of setting up search strategies in memory semantics and oral language.&#xD;
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.</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>An MRI lasting 30 minutes is programmed</description>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Apathy Motivation Index</intervention_name>
    <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 &quot;behavioral&quot; apathy and &quot;social&quot; apathy.&#xD;
&quot;Emotional&quot;.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients:&#xD;
&#xD;
          -  60 years and above&#xD;
&#xD;
          -  Major depressive disorder (either late-onset or early onset)&#xD;
&#xD;
          -  Ambulatory settings&#xD;
&#xD;
          -  Both uni and bipolar depression will be considered Healthy controls&#xD;
&#xD;
          -  60 years and above&#xD;
&#xD;
          -  No psychiatric disorders, including no major depressive disorder&#xD;
&#xD;
          -  No non-inclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients and healthy controls&#xD;
&#xD;
          -  Major cognitive disorders (&lt; 125 on the Mattis dementia rating scale and a major&#xD;
             cognitive disorders diagnostic according to the DSM5 (Diagnostic and Statistical&#xD;
             Manual of Mental Disorders) criteria).&#xD;
&#xD;
          -  Other neurological conditions (stroke, Parkinson's disease and seizures), severe and&#xD;
             inflammatory disorders (ex: severe arthroses which limits movements, spondylarthritis)&#xD;
&#xD;
          -  Severe sarcopenia: speed walk &lt; 1 meter/second&#xD;
&#xD;
          -  Extrapyramidal syndrome&#xD;
&#xD;
          -  High suicidal risk&#xD;
&#xD;
          -  Anti-psychotic prescription&#xD;
&#xD;
          -  Participant who are unable to provide clear consent, under legal protection&#xD;
&#xD;
          -  MRI contra-indication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Mémoire de Ressources et de Recherche (CMRR),</name>
      <address>
        <city>Nice</city>
        <zip>06100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bretonneau,CIC</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Radiologie- Neuroradiologie,CHU bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03807167
org study id: 35RC18_8833_ACTIDEP
nct id: NCT03807167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Actimetry
time frame: 3 days
description: Measure of actimetry: immobility, transfer, walking, movement given by the accelerometer
measure: grey matter density
time frame: at Day 3 (+/- 2 days)
description: Magnetic Resonance Imaging brain metrics: grey matter density
measure: cortical thickness
time frame: at Day 3 (+/- 2 days)
description: Magnetic Resonance Imaging brain metrics: cortical thickness;
measure: diffusion tensor imaging,
time frame: at Day 3 (+/- 2 days)
description: Magnetic Resonance Imaging brain metrics: diffusion tensor imaging,
measure: Rest functional connectivity analysis
time frame: at Day 3 (+/- 2 days)
description: Magnetic Resonance Imaging brain metrics: regional cerebral blood flow
measure: pulsatility.
time frame: at Day 3 (+/- 2 days)
description: Magnetic Resonance Imaging brain metrics: pulsatility.
arm group label: Patients
arm group type: Experimental
arm group label: healthy controls
arm group type: Active Comparator
intervention type: Other
intervention name: Mattis Dementia Rating Scale
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.
arm group label: Patients
intervention type: Other
intervention name: Unified Parkinson 's Disease Rating Scale-III
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.
arm group label: Patients
intervention type: Other
intervention name: Mini Neuropsychiatric Investigation
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.
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: Montgomery and Asberg depression Rating Scale
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).
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: Clinical Global Impression
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.
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: Apathy diagnostic criteria
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.
arm group label: Patients
intervention type: Other
intervention name: walking speed test
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.
arm group label: Patients
intervention type: Other
intervention name: accelerometer presentation
description: accelerometer presentation and pose
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: data acquisition from the accelerometer
description: withdrawal of the accelerometer and data acquisition from the accelerometer
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: Apathy Evaluation Scale,
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.
arm group label: Patients
intervention type: Other
intervention name: fatigue Visual Analog Scale
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.
arm group label: Patients
intervention type: Other
intervention name: executive function
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.
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: MRI
description: An MRI lasting 30 minutes is programmed
arm group label: Patients
arm group label: healthy controls
intervention type: Other
intervention name: Apathy Motivation Index
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".
arm group label: Patients
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder