DepLIPIDO: DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05099341

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Other: HDRS-17 depression scale Biological: Blood sampling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with recurrent depression with a number of depressive episodes ≥ 3	Other: HDRS-17 depression scale Measuring the severity of depression Biological: Blood sampling 3 tubes of 5 ml
Experimental: Patients with a first depressive episode	Other: HDRS-17 depression scale Measuring the severity of depression Biological: Blood sampling 3 tubes of 5 ml
Active Comparator: Healthy, non-depressed subjects	Other: HDRS-17 depression scale Measuring the severity of depression Biological: Blood sampling 3 tubes of 5 ml

Arm

Intervention/Treatment

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

Other: HDRS-17 depression scale

Measuring the severity of depression

Biological: Blood sampling

3 tubes of 5 ml

Experimental: Patients with a first depressive episode

Other: HDRS-17 depression scale

Measuring the severity of depression

Biological: Blood sampling

3 tubes of 5 ml

Active Comparator: Healthy, non-depressed subjects

Other: HDRS-17 depression scale

Measuring the severity of depression

Biological: Blood sampling

3 tubes of 5 ml

Outcome Measures

Primary Outcome Measures

Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages [At baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourgogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT05099341

Other Study ID Numbers:

CHAUVET CRBFC-E 2019

First Posted:

Oct 29, 2021

Last Update Posted:

Oct 29, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Oct 29, 2021