NCT05099341

Brief Summary

Depression is a disabling condition in terms of psychosocial alteration and also in terms of physical comorbidities. Depression doubles the risk of myocardial infarction compared with the general population, and this cardiovascular comorbidity leads to an increase in mortality in patients suffering from depression, even exceeding suicide-related mortality. It is therefore important to better understand the mechanisms linking depression and cardiovascular disease. Among the hypotheses that may account for the increased cardiovascular risk in patients with depression, lipid abnormalities are likely to play a crucial role. Thus, qualitative and functional abnormalities in HDL lipoproteins are an important line of research, insofar as these lipid abnormalities have been recognized as important atherogenic abnormalities in populations at high cardiovascular risk, which is the case of patients with depression. In this clinical, epidemiological and scientific context, a collaborative study undertaken by both the Department of Psychiatry of the Dijon Bourgogne University Hospital of and the INSERM LNC-UMR 1231 (PADYS) Laboratory of the UNIVERSITY OF BOURGOGNE FRANCHE-COMTE is an original translational research project, and the first study to perform a lipidomic analysis of HDL, coupled with a functional analysis of these lipoproteins in depression.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
16mo left

Started Oct 2021

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2021Oct 2027

Study Start

First participant enrolled

October 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

6 years

First QC Date

October 4, 2021

Last Update Submit

September 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages

    At baseline

Study Arms (3)

Patients with recurrent depression with a number of depressive episodes ≥ 3

EXPERIMENTAL
Other: HDRS-17 depression scaleBiological: Blood sampling

Patients with a first depressive episode

EXPERIMENTAL
Other: HDRS-17 depression scaleBiological: Blood sampling

Healthy, non-depressed subjects

ACTIVE COMPARATOR
Other: HDRS-17 depression scaleBiological: Blood sampling

Interventions

Measuring the severity of depression

Healthy, non-depressed subjectsPatients with a first depressive episodePatients with recurrent depression with a number of depressive episodes ≥ 3
Blood samplingBIOLOGICAL

3 tubes of 5 ml

Healthy, non-depressed subjectsPatients with a first depressive episodePatients with recurrent depression with a number of depressive episodes ≥ 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FOR PATIENTS WITH RECURRENT DEPRESSION :
  • Patient who has provided oral consent
  • Adult with moderate to severe depression according to DSM-5 criteria (Hamilton HDRS-17 score ≥ 18), with a number of depressive episodes ≥ 3
  • PATIENTS PRESENTING WITH A FIRST DEPRESSIVE EPISODE
  • Patient who has provided oral consent
  • Adult with moderate to severe characterized depression according to DSM-5 criteria (Hamilton HDRS-17 scale score ≥ 18) presenting with a first depressive episode.
  • CONTROLS
  • Person who has provided oral consent
  • Adult who has never shown signs of depression

You may not qualify if:

  • Person not affiliated with national health insurance
  • Person subject to a measure of legal protection (curatorship, guardianship)
  • Pregnant or breastfeeding women
  • Adult unable to express consent
  • Minors
  • Person with a metabolic syndrome (according to NCEP/ATP-III criteria: 3 of the following 5 criteria: Waist circumference ≥ 102 cm in males and ≥ 88cm in females, Triglycerides \> 1.50 g/L, HDL-Cholesterol \< 0.40 g/L in H, HDL-Cholesterol \< 0.50 g/L in F, Blood pressure ≥130/85mmHg, Fasting blood glucose ≥ 1.10 g/L),
  • Person with type 1 or type 2 diabetes,
  • Person with a mild depressive episode (HDRS-17\<18),
  • Person with concomitant antipsychotic treatment
  • Person with bipolar disorder,
  • Person with a moderate to severe alcohol use disorder according to DSM-5 criteria
  • Person with schizophrenia,
  • Person with a persistent delusional disorder,
  • Person with an autism spectrum disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 29, 2021

Study Start

October 1, 2021

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations