DepressionDepLIPIDONCT05099341
DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls
A study testing HDRS-17 depression scale and Blood sampling in people with Depression, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- HDRS-17 depression scale and Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- CONTROLS
- Person who has provided oral consent
- Adult who has never shown signs of depression
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Jean-Christophe CHAUVET-GELINIER, 03 80 29 37 69, jean-christophe.chauvet-gelinier@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Depression
- Being tested
- HDRS-17 depression scale, Blood sampling
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDRS-17 depression scaleOther
Measuring the severity of depression
Blood samplingBiological
3 tubes of 5 ml
| Study group | Role | What they receive |
|---|---|---|
| Patients with recurrent depression with a number of depressive episodes ≥ 3 | Experimental | Not described Receives: Other: HDRS-17 depression scale; Biological: Blood sampling |
| Patients with a first depressive episode | Experimental | Not described Receives: Other: HDRS-17 depression scale; Biological: Blood sampling |
| Healthy, non-depressed subjects | Active comparator | Not described Receives: Other: HDRS-17 depression scale; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Oct 2021
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099341
- Sponsor's protocol ID
- CHAUVET CRBFC-E 2019
- Acronym
- DepLIPIDO
- Status last verified
- Sep 2025
- First submitted
- 4 Oct 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls
- ClinicalTrials.gov ID
- NCT05099341
- Acronym / sponsor ID
- DepLIPIDO / CHAUVET CRBFC-E 2019
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with recurrent depression with a number of depressive episodes ≥ 3 | Experimental | Other: HDRS-17 depression scale, Biological: Blood sampling |
| Patients with a first depressive episode | Experimental | Other: HDRS-17 depression scale, Biological: Blood sampling |
| Healthy, non-depressed subjects | Active comparator | Other: HDRS-17 depression scale, Biological: Blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- FOR PATIENTS WITH RECURRENT DEPRESSION :
- PATIENTS PRESENTING WITH A FIRST DEPRESSIVE EPISODE
- CONTROLS
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDRS-17 depression scaleMeasuring the severity of depression | Other | Healthy, non-depressed subjects, Patients with a first depressive episode, Patients with recurrent depression with a number of depressive episodes ≥ 3 |
| Blood sampling3 tubes of 5 ml | Biological | Healthy, non-depressed subjects, Patients with a first depressive episode, Patients with recurrent depression with a number of depressive episodes ≥ 3 |
Primary outcome
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDRS-17 depression scale and Blood sampling in people with Depression, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe CHAUVET-GELINIER (03 80 29 37 69, jean-christophe.chauvet-gelinier@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of cholesterol efflux by fluorescent method on THP-1 cell derived macrophages (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.