- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05099341
DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls (DepLIPIDO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Christophe CHAUVET-GELINIER
- Phone Number: 03 80 29 37 69
- Email: jean-christophe.chauvet-gelinier@chu-dijon.fr
Study Locations
-
-
-
Dijon, France, 21000
- Recruiting
- Chu Dijon Bourgogne
-
Contact:
- Jean-Christophe CHAUVET-GELINIER
- Phone Number: 03 80 29 37 69
- Email: jean-christophe.chauvet-gelinier@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with recurrent depression with a number of depressive episodes ≥ 3
|
Measuring the severity of depression
3 tubes of 5 ml
|
|
Experimental: Patients with a first depressive episode
|
Measuring the severity of depression
3 tubes of 5 ml
|
|
Active Comparator: Healthy, non-depressed subjects
|
Measuring the severity of depression
3 tubes of 5 ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages
Time Frame: At baseline
|
At baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAUVET CRBFC-E 2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.