Late Life DepressionCAnD'ID-METRONCT06663891
Chronic Anergic Depression IDentification - Magnetic Resonance Imaging Exploration in the Elderly of Traits Related to Onset
A study testing Functional MRI with EEG per MRI in people with Late Life Depression, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Depression in the elderly, or "late life depression" (LLD), is often considered to be homogeneous, legitimizing standardized treatment. Yet the literature suggests that there are different forms of LLD, with different pathophysiology, course and treatment. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Late Life Depression
- What is being tested?
- Functional MRI with EEG per MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 60 (inclusive) to 90 years (exclusive)
- Patient presenting with active or remitted anergic depression according to the operational criteria of the "Chronic Anergic Depression Open Trial" (1) confirmed by two psychiatrists involved in the study:
- Early Onset Depression (EOD) group: with at least one history of depression before age 60
- Late Onset Depression (LOD) group: no history of depression before age 60
- Patient able to understand the objectives/risks of the research and give informed consent
- Patient affiliated to a health insurance social protection scheme, beneficiary or dependent
Who cannot join
- Contraindication to an MRI scan (including claustrophobia)*
- Psychiatric or organic comorbidity that may interfere with the interpretation of results (e.g. neurovascular disease, psychotic disorder, proven neurodegenerative disease)
- Concomitant treatment that may interfere with the interpretation of results (e.g. interferons, corticosteroids)
- Patient in exclusion period (from a previous or current study)
- Current protective measure (curatorship, guardianship)
- Patient under legal protection * presence of non-removable ferromagnetic foreign body, prosthesis, pacemaker, defibrillator, neurostimulation device, medications delivered by an implanted pump, vascular clip or stent, heart valve or ventricular shunt, implanted device incompatible with 3 Tesla MRI exam, claustrophobia, epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, Grand Est, 67000
Ludovic DORMEGNY-JEANJEAN, 0033388116353, l.jeanjean@unistra.fr
About this study
Official title: Identification of Trait Markers Differentiating Late-onset Depression From Early-onset Depression in Chronic Anergic Depression in the Elderly
Depression in the elderly, or "late life depression" (LLD), is often considered to be homogeneous, legitimizing standardized treatment. Yet the literature suggests that there are different forms of LLD, with different pathophysiology, course and treatment.
Our experience has led us to identify an "anergic" form, marked by adynamia and anhedonia (anergic depression, AnD). Highly represented among LLDs, it readily resists the usual antidepressants, so that its course is often chronic. Thanks to the "Chronic Anergic Depression Open Trial", the investigators were able to show that AnD responds to dopaminergic (DA) molecules. Therefore the invastigators hypothesized a pathophysiology linked to dysfunction of the mesolimbic DA system.
Read more
However, not all patients would present the same form: two subgroups could be isolated, each contributing equally. The first corresponds to patients for whom the episode is a recurrence, the so-called "early onset depression" (EOD). The first episode occurs at 34 ±16 years of age and is frequently associated with a personality disorder (73%). The index episode usually lasts 6 ±3 years and is typically associated with anxiety (96%).
The second group corresponds to the onset of primary depression after the age of 60, known as "late onset depression" (LOD). The index episode occurs at around 71 ±6 years of age, in people with no premorbid personality disorders. The episode is shorter (3 ±1 years) and anxiety is frequent (75%) but less marked. These patients showed a high propensity for a course compatible with synucleinopathies, but often less rapid than that of the classic forms of these diseases.
The investigators hypothesize that within AnD, EOD and LOD present different pathophysiologies, and that this difference is observable on functional magnetic resonance imaging (MRI): LOD patients should present a greater reduction in functional connectivity in the mesolimbic system. The investigators make the subsidiary hypothesis that LODs also show a structural alteration observable with other types of MRI measurements, i.e. multiparametric imaging.
- Conditions
- Late Life Depression
- Being tested
- Functional MRI with EEG per MRI
- Keywords
- Late life depression neuroimaging,, connectivity,, apathy,, dopaminergic system
- Medical subject headings
- Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI with EEG per MRIOther
2 MRI examinations will be carried out on a Siemens Vida® MRI ( Siemens®, Erlangen, Germany) 3 Tesla. During this study, no MRI examination requires the injection of a contrast agent.
Different sequences, according to several acquisition modalities, will be performed during each MRI. The structural sequences (T1 and T2, MPRAGE) will highlight any lesions in the form of atrophies and/or vascular lesions in the participants, also subject to inter-individual differences. The examination will also involve a quantitative multiparametric acquisition with 8 modalities (R1, R2, Radial and Axial Diffusion in Diffusion Tensor, dispersion, orientation and density index of neurites by NODDI, the Macromolecular Proton Fraction, measurement of magnetic susceptibility and R2*) to characterize tissue properties. Functional imaging (in resting state, during film viewing and performance of cognitive tasks in ASL, BOLD and multiband) will allow analysis of the primary endpoint - functional connectivity,
| Study group | Role | What they receive |
|---|---|---|
| Early Onset Depression (EOD) | Other | Elderly depressed patients (≥ 60 years and < 90 years) suffering from active or remitted anergic depression and who have at least one history of a depressive episode strictly before the age of 60 years Receives: Other: Functional MRI with EEG per MRI |
| Late Onset Depression (LOD) | Other | Elderly depressed patients (≥ 60 years and < 90 years) suffering from active or remitted anergic depression and who do not have a history of a depressive episode strictly before the age of 60 years. Receives: Other: Functional MRI with EEG per MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTA - mesolimbic system functional connectivity
Functional connectivity, observed at the subpopulation level, between the ventral tegmental area (VTA) and regions of the mesolimbic system (i.e.: ventral striatum and pallidum, amygdala, and subgenual anterior cingulate [with separate analysis of Brodmann area 25] and ventromedial prefrontal cortex), obtained by ROI to ROI analysis.
Measured: Day 1
Secondary outcomes (2)
Perfusion of the mesolimbic system
Mean cerebral perfusion rates measured by arterial spin labeling (ASL) in regions of interest (i.e.: ventral tegmental area, ventral striatum and pallidum, amygdala, and subgenual anterior cingulate [with separate analysis of Brodmann area 25] and ventromedial prefrontal cortex).
Measured: Day 1
Perfusion of the mesolimbic system
Mean cerebral perfusion rates measured by arterial spin labeling (ASL) in regions of interest (i.e.: ventral tegmental area, ventral striatum and pallidum, amygdala, and subgenual anterior cingulate [with separate analysis of Brodmann area 25] and ventromedial prefrontal cortex).
Measured: Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start17 Jul 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic DORMEGNY-JEANJEAN Doctor, Principal investigator, Department of Physiology and Funtional Explorations at Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663891
- Sponsor's protocol ID
- 9203
- Other IDs
- 2024-A02236-41
- Acronym
- CAnD'ID-METRO
- Status last verified
- Aug 2026
- First submitted
- 23 Oct 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Trait Markers Differentiating Late-onset Depression From Early-onset Depression in Chronic Anergic Depression in the Elderly
- ClinicalTrials.gov ID
- NCT06663891
- Acronym / sponsor ID
- CAnD'ID-METRO / 9203
- Conditions
- Late Life Depression
- Keywords
- Late life depression neuroimaging,, connectivity,, apathy,, dopaminergic system
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Oct 2024 (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.
Depression in the elderly, or "late life depression" (LLD), is often considered to be homogeneous, legitimizing standardized treatment. Yet the literature suggests that there are different forms of LLD, with different pathophysiology, course and treatment.
Our experience has led us to identify an "anergic" form, marked by adynamia and anhedonia (anergic depression, AnD). Highly represented among LLDs, it readily resists the usual antidepressants, so that its course is often chronic. Thanks to the "Chronic Anergic Depression Open Trial", the investigators were able to show that AnD responds to dopaminergic (DA) molecules. Therefore the invastigators hypothesized a pathophysiology linked to dysfunction of the mesolimbic DA system.
However, not all patients would present the same form: two subgroups could be isolated, each contributing equally. The first corresponds to patients for whom the episode is a recurrence, the so-called "early onset depression" (EOD). The first episode occurs at 34 ±16 years of age and is frequently associated with a personality disorder (73%). The index episode usually lasts 6 ±3 years and is typically associated with anxiety (96%).
The second group corresponds to the onset of primary depression after the age of 60, known as "late onset depression" (LOD). The index episode occurs at around 71 ±6 years of age, in people with no premorbid personality disorders. The episode is shorter (3 ±1 years) and anxiety is frequent (75%) but less marked. These patients showed a high propensity for a course compatible with synucleinopathies, but often less rapid than that of the classic forms of these diseases.
The investigators hypothesize that within AnD, EOD and LOD present different pathophysiologies, and that this difference is observable on functional magnetic resonance imaging (MRI): LOD patients should present a greater reduction in functional connectivity in the mesolimbic system. The investigators make the subsidiary hypothesis that LODs also show a structural alteration observable with other types of MRI measurements, i.e. multiparametric imaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Onset Depression (EOD) | Other | Other: Functional MRI with EEG per MRIElderly depressed patients (≥ 60 years and < 90 years) suffering from active or remitted anergic depression and who have at least one history of a depressive episode strictly before the age of 60 years |
| Late Onset Depression (LOD) | Other | Other: Functional MRI with EEG per MRIElderly depressed patients (≥ 60 years and < 90 years) suffering from active or remitted anergic depression and who do not have a history of a depressive episode strictly before the age of 60 years. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 60 (inclusive) to 90 years (exclusive)
- Patient presenting with active or remitted anergic depression according to the operational criteria of the "Chronic Anergic Depression Open Trial" (1) confirmed by two psychiatrists involved in the study:
- Patient able to understand the objectives/risks of the research and give informed consent
- Patient affiliated to a health insurance social protection scheme, beneficiary or dependent
Key exclusion criteria (6 listed)
- Contraindication to an MRI scan (including claustrophobia)*
- Psychiatric or organic comorbidity that may interfere with the interpretation of results (e.g. neurovascular disease, psychotic disorder, proven neurodegenerative disease)
- Concomitant treatment that may interfere with the interpretation of results (e.g. interferons, corticosteroids)
- Patient in exclusion period (from a previous or current study)
- Current protective measure (curatorship, guardianship)
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 |
|---|---|---|
| Functional MRI with EEG per MRI2 MRI examinations will be carried out on a Siemens Vida® MRI ( Siemens®, Erlangen, Germany) 3 Tesla. During this study, no MRI examination requires the injection of a contrast agent. Different sequences, according to several acquisition modalities, will be performed during each MRI. The structural sequences (T1 and T2, MPRAGE) will highlight any lesions in the form of atrophies and/or vascular lesions in the participants, also subject to inter-individual differences. The examination will also involve a quantitative multiparametric acquisition with 8 modalities (R1, R2, Radial and Axial Diffusion in Diffusion Tensor, dispersion, orientation and density index of neurites by NODDI, the Macromolecular Proton Fraction, measurement of magnetic susceptibility and R2*) to characterize tissue properties. Functional imaging (in resting state, during film viewing and performance of cognitive tasks in ASL, BOLD and multiband) will allow analysis of the primary endpoint - functional connectivity, | Other | Early Onset Depression (EOD), Late Onset Depression (LOD) |
Primary outcome
VTA - mesolimbic system functional connectivity
Time frame: Day 1
Functional connectivity, observed at the subpopulation level, between the ventral tegmental area (VTA) and regions of the mesolimbic system (i.e.: ventral striatum and pallidum, amygdala, and subgenual anterior cingulate [with separate analysis of Brodmann area 25] and ventromedial prefrontal cortex), obtained by ROI to ROI analysis.
2 secondary outcomes
Perfusion of the mesolimbic system
Time frame: Day 1
Perfusion of the mesolimbic system
Time frame: Day 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Ludovic DORMEGNY-JEANJEAN Doctor principal investigator
Department of Physiology and Funtional Explorations at Strasbourg University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional MRI with EEG per MRI in people with Late Life Depression, run by University Hospital, Strasbourg, France at 1 site 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic DORMEGNY-JEANJEAN Doctor (+33388116921, l.jeanjean@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTA - mesolimbic system functional connectivity (time frame: Day 1). 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 21 Aug 2026.