Major Depressive Episode Clinical Trial
— NISISOfficial title:
Neuroinflammation, Serotonin, Impulsivity and Suicide
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.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | November 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 : - 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 Exclusion Criteria: - 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) |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of interleukin 2 (Il2) in a blood sample | Comparison of Il2 levels between patients with and without suicidal behaviour | inclusion visit | No |
Secondary | 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 | inclusion visit | No |
Secondary | 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 | inclusion visit | No |
Secondary | 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 | inclusion visit | No |
Secondary | 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 | inclusion visit | No |
Secondary | 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) | inclusion visit | No |
Secondary | 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) | inclusion visit | No |
Secondary | 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) | inclusion visit | No |
Secondary | 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 | inclusion visit | No |
Secondary | 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 | inclusion visit | No |
Secondary | 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. | at 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03256162 -
Ketamine as an Adjunctive Therapy for Major Depression
|
Phase 1 | |
Completed |
NCT01944293 -
Ketamine for Suicidality in Bipolar Depression
|
Phase 1/Phase 2 | |
Recruiting |
NCT01441505 -
A Study of Ketamine as an Antidepressant
|
Phase 2 | |
Active, not recruiting |
NCT03487926 -
Microglial Activation in Inflammatory Bowel Disease
|
||
Recruiting |
NCT04939649 -
Ketamine as an Adjunctive Therapy for Major Depression (2)
|
Phase 3 | |
Recruiting |
NCT05028738 -
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
|
N/A | |
Recruiting |
NCT03646058 -
Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode
|
Phase 3 | |
Not yet recruiting |
NCT06117397 -
A Text Messaging Intervention to Reduce Perinatal Depression Risk
|
N/A | |
Completed |
NCT03735576 -
Cognitive Behavioural Therapy for the Treatment of Late Life Depression
|
N/A | |
Recruiting |
NCT04999553 -
Left vs. Right Non-Inferiority Trial
|
N/A | |
Completed |
NCT03716869 -
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder
|
N/A | |
Terminated |
NCT01099592 -
Antidepressants to Promote Recovery of Cardiac Patients Suffering From Depression
|
Phase 4 | |
Completed |
NCT03752853 -
Stress Systems and Psychotherapy in Depression
|
N/A | |
Recruiting |
NCT04480918 -
University of Iowa Interventional Psychiatry Service Patient Registry
|
||
Recruiting |
NCT04130958 -
Circuit-Based Approach to Suicide: Biomarkers, Predictors, and Novel Therapeutics
|
N/A | |
Completed |
NCT03190772 -
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
|
N/A | |
Recruiting |
NCT04832750 -
Depression-Reduction by Accelerated Personalized NeuroModulation and Its Effects on Sleep
|
||
Terminated |
NCT02839798 -
NeoSync TMS Treatment for Bipolar I Depression
|
Phase 2 | |
Completed |
NCT00852592 -
Light Therapy for Bipolar Disorder. Efficacy of Light Therapy for Bipolar Depression: A Randomized Controlled Trial
|
Phase 3 | |
Terminated |
NCT05063604 -
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression
|
Phase 2 |