Chronic Anergic Depression IDentification - Magnetic Resonance Imaging Exploration in the Elderly of Traits Related to Onset

NCT06663891 | Not Yet Recruiting

• 2 other identifiers: 92032024-A02236-41
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Late Life Depression

Keywords

Late life depression neuroimaging,; connectivity,; apathy,; dopaminergic system

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (2)

• Perfusion of the mesolimbic system

  Day 1

• Perfusion of the mesolimbic system

  Day 13

Other Outcomes (17)

• Quantitative parameters measured in multiparametric MRI in the ventral tegmental area

  Day 1

• Quantitative parameters measured in multiparametric MRI in the ventral tegmental area

  Day 13

• Θ / β powers ratio

  Day 1

Study Arms (2)

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

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.

Other: Functional MRI with EEG per MRI

Interventions

Functional MRI with EEG per MRI OTHER

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,

Early Onset Depression (EOD); Late Onset Depression (LOD)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Lethargy

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ludovic DORMEGNY-JEANJEAN Doctor

  Department of Physiology and Funtional Explorations at Strasbourg University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ludovic DORMEGNY-JEANJEAN Doctor

CONTACT

+33388116921; l.jeanjean@unistra.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 29, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share