Major Depressive EpisodeNISISNCT02824081
Neuroinflammation, Serotonin, Impulsivity and Suicide
A study testing Blood sample in people with Major Depressive Episode and Suicidal Behavior, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB…) and stressful conditions (early life adversity). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Episode, Suicidal Behavior
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18 and 65
- Main diagnosis of major depressive episode (DSM-IV criteria)
- Having signed the informed consent
- Able to understand nature, aims, and methodology of the study
- Specifics Inclusion criteria:
- Depressed patients with suicide attempt history :
Show all 9Show fewer
- Have done in his lifetime at least one suicide attempt (however the period of time between inclusion and suicide attempt)
- Depressed patients without suicide attempt history :
- Had never realized suicide attempt in his lifetime
Who cannot join
- Patients suffering from inflammatories pathology
- Antibiotic or anti-inflammatory current treatment
- Pregnancy
- Participation in another clinical trial with an exclusion period
- Patient on protective measures (guardianship or trusteeship)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Montpellier, 34295
Catherine GENTY, MD, +33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
About this study
Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB…) and stressful conditions (early life adversity).
Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation.
Read more
Recent evidences also suggest that inflammatory mediators play a critical role in SB.
The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB.
In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.
Read the detailed description
Over one year, we will recruit 280 patients suffering from a major depressive episode with (n=140) and without any history of suicide attempt (n=140), from a specialized clinic for mood disorders and SB.
First visit : clinical, biological and neuropsychological assessment
Second visit, at 6 month : Follow-up visit in the department or interview by telephone in order to assess suicidal ideations or suicide attempts since the inclusion.
- Conditions
- Major Depressive Episode, Suicidal Behavior
- Being tested
- Blood sample
- Keywords
- Psychiatry, Depressive disorder, Suicide, Inflammation
- Medical subject headings
- Depressive Disorder, Suicide, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample in order to study inflammatory biomarkers and genetics purpose
| Study group | Role | What they receive |
|---|---|---|
| Depressive patients | Other | Blood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of interleukin 2 (Il2) in a blood sample
Comparison of Il2 levels between patients with and without suicidal behaviour
Measured: inclusion visit
Secondary outcomes (10)
Rate of inflammation markers (Interleukin 1, 4, 6, 8, 10, Tumor necrosis factor alpha (TNF-a), Interferon gamma (IFNg), Vascular endothelial growth factor (VEGF), kynurenin and c-reactive protein (CRP) in a blood sample
Comparison of the levels of theses markers between patients with and without suicidal behaviour
Measured: inclusion visit
Rate of inflammation markers and suicide attempt
Comparison of rate bloodmarkers inflammation (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with latest suicide attempt and depressed patients with an history of suicide attempt
Measured: inclusion visit
Rate of inflammation markers and violent suicide attempt
Comparison of rate bloodmarkers inflammation (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without violent suicide attempt
Measured: inclusion visit
Rate of inflammation markers and suicide ideations
Comparison of rate bloddmarkers (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) in depressed patients with and without current suicide ideation
Measured: inclusion visit
Relation between markers of inflammation and suicidal behavior characteristics
Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and suicidal behaviour characteristics (the last and the most serious) (intentionality, planification, lethality)
Measured: inclusion visit
Relation between markers of inflammation and impulsivity
Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and impulsivity (by Baratt Impulsivity Scale and neuropsychological tests)
Measured: inclusion visit
Relation between markers of inflammation and psychological pain
Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and psychological pain (by Likert scale)
Measured: inclusion visit
Relation between markers of inflammation and child abuse
Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and child abuse
Measured: inclusion visit
Relation between markers of inflammation and gene expression
Studying relations with bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) and gene expression of 5HT2B receptor
Measured: inclusion visit
Markers of inflammation as a risk factor for suicidal behavior
Studying bloodmarkers inflammation rate (Il1, 4, 6, 8, 10, TNF-a, IFNg, VEGF, kynurenine and CRP) as suicidal behaviour risk factor (suicide ideations and/or suicide attempt) with a 6 months follow-up.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824081
- Sponsor's protocol ID
- UF9467
- Other IDs
- 2014-A01313-44
- Acronym
- NISIS
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation, Serotonin, Impulsivity and Suicide
- ClinicalTrials.gov ID
- NCT02824081
- Acronym / sponsor ID
- NISIS / UF9467
- Conditions
- Major Depressive Episode, Suicidal Behavior
- Keywords
- Psychiatry, Depressive disorder, Suicide, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- 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.
Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB…) and stressful conditions (early life adversity).
Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation.
Recent evidences also suggest that inflammatory mediators play a critical role in SB.
The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB.
In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.
Detailed description
Over one year, we will recruit 280 patients suffering from a major depressive episode with (n=140) and without any history of suicide attempt (n=140), from a specialized clinic for mood disorders and SB.
First visit : clinical, biological and neuropsychological assessment
Second visit, at 6 month : Follow-up visit in the department or interview by telephone in order to assess suicidal ideations or suicide attempts since the inclusion.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressive patients | Other | Biological: Blood sampleBlood samples (inflammatory biomarkers and genetic purpose) on depressive patients with or without story of suicidal behavior |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ages of 18 and 65
- Main diagnosis of major depressive episode (DSM-IV criteria)
- Having signed the informed consent
- Able to understand nature, aims, and methodology of the study
- Depressed patients with suicide attempt history :
Key exclusion criteria (5 listed)
- Patients suffering from inflammatories pathology
- Antibiotic or anti-inflammatory current treatment
- Pregnancy
- Participation in another clinical trial with an exclusion period
- Patient on protective measures (guardianship or trusteeship)
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 |
|---|---|---|
| Blood sampleBlood sample in order to study inflammatory biomarkers and genetics purpose | Biological | Depressive patients |
Primary outcome
Rate of interleukin 2 (Il2) in a blood sample
Time frame: inclusion visit
Comparison of Il2 levels between patients with and without suicidal behaviour
10 secondary outcomes
Rate of inflammation markers (Interleukin 1, 4, 6, 8, 10, Tumor necrosis factor alpha (TNF-a), Interferon gamma (IFNg), Vascular endothelial growth factor (VEGF), kynurenin and c-reactive protein (CRP) in a blood sample
Time frame: inclusion visit
Rate of inflammation markers and suicide attempt
Time frame: inclusion visit
Rate of inflammation markers and violent suicide attempt
Time frame: inclusion visit
Rate of inflammation markers and suicide ideations
Time frame: inclusion visit
Relation between markers of inflammation and suicidal behavior characteristics
Time frame: inclusion visit
Relation between markers of inflammation and impulsivity
Time frame: inclusion visit
Relation between markers of inflammation and psychological pain
Time frame: inclusion visit
Relation between markers of inflammation and child abuse
Time frame: inclusion visit
Relation between markers of inflammation and gene expression
Time frame: inclusion visit
Markers of inflammation as a risk factor for suicidal behavior
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Major Depressive Episode and Suicidal Behavior, run by University Hospital, Montpellier 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 5 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: status not confirmed, as of the sponsor's last update on 6 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of interleukin 2 (Il2) in a blood sample (time frame: inclusion visit). 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 6 Jul 2016.