Clinical trial

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

Name
CHAUVET CRBFC-E 2019
Description
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 arms
Trial start
2021-10-01
Estimated PCD
2025-10-01
Trial end
2025-10-01
Status
Recruiting
Treatment
HDRS-17 depression scale
Measuring the severity of depression
Arms:
Healthy, non-depressed subjects, Patients with a first depressive episode, Patients with recurrent depression with a number of depressive episodes ≥ 3
Blood sampling
3 tubes of 5 ml
Arms:
Healthy, non-depressed subjects, Patients with a first depressive episode, Patients with recurrent depression with a number of depressive episodes ≥ 3
Size
90
Primary endpoint
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages
At baseline
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2023-09-07

1 organization

1 product

1 indication