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Clinical Trials/NCT06663891
NCT06663891
Not yet recruiting
Not Applicable

Identification of Trait Markers Differentiating Late-onset Depression from Early-onset Depression in Chronic Anergic Depression in the Elderly

University Hospital, Strasbourg, France0 sites50 target enrollmentFebruary 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Late Life Depression
Sponsor
University Hospital, Strasbourg, France
Enrollment
50
Primary Endpoint
VTA - mesolimbic system functional connectivity
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2025
End Date
March 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Perfusion of the mesolimbic system(Day 13)

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