Back to resultsDEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls (DepLIPIDO)
Primary Purpose
Depression
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HDRS-17 depression scale
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Depression
Eligibility Criteria
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.
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Patients with recurrent depression with a number of depressive episodes ≥ 3
Patients with a first depressive episode
Healthy, non-depressed subjects
Arm Description
Outcomes
Primary Outcome Measures
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages
Secondary Outcome Measures
Full Information
NCT ID
NCT05099341
First Posted
October 4, 2021
Last Updated
September 6, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT05099341
Brief Title
DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls
Acronym
DepLIPIDO
Official Title
DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with recurrent depression with a number of depressive episodes ≥ 3
Arm Type
Experimental
Arm Title
Patients with a first depressive episode
Arm Type
Experimental
Arm Title
Healthy, non-depressed subjects
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
HDRS-17 depression scale
Intervention Description
Measuring the severity of depression
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
3 tubes of 5 ml
Primary Outcome Measure Information:
Title
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe CHAUVET-GELINIER
Phone
03 80 29 37 69
Email
jean-christophe.chauvet-gelinier@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe CHAUVET-GELINIER
Phone
03 80 29 37 69
Email
jean-christophe.chauvet-gelinier@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls
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