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

Depression Clinical Trial

— DepLIPIDO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099341
• Other study ID #: CHAUVET CRBFC-E 2019
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Jean-Christophe CHAUVET-GELINIER
• Phone: 03 80 29 37 69
• Email: jean-christophe.chauvet-gelinier[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• HDRS-17 depression scale
Measuring the severity of depression

Biological:
• Blood sampling
3 tubes of 5 ml

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages		At baseline