Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02214511
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2014-06-30
Brief Title:
Biomarkers of Social Sensitivity in Major Depression
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Etude de la sensibilité Aux Signaux Sociaux Dans la dépression Modulateurs Psychologiques Comportementaux et Inflammatoires
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSO
Brief Summary:
Major depression disorder MDD is a frequent and disabling mental disorder with great risk of recurrence and chronicity Interpersonal factors are among the strongest predictors of the course and duration of an episode of depression More specifically social rejection is one of the most environmental risk factors of MDD Targeted rejection predicts hastened onset of major depression On the other hand healthy subject show prosocial behavior after social rejection to reconnect to new source of social interaction In addition to the potential impact of social exclusion on MDD onset depressed patients may be more prone to be rejected as they encounter interpersonal difficulties and may less be able to reconnect to the social group after rejection
Recent neuroimaging data show that brain processing of social exclusion activate brain regions that are central to the pathophysiology of MDD Some of these regions are also known to be activated during physical pain and may contribute to the aversive dimension of the experienced rejection Pro-inflammatory cytokines are involved in MDD physiopathology and can induce social withdrawal behavior Inflammation can modulate social interactions in mammals Moreover after a social stress such as social rejection blood cytokines increase At a cognitive level self-esteem can modulate the sensitivity to social rejection
The major objective of the trial is to study sensitivity to social signals in MDD patient compared to healthy subject
The investigators hypothesize in MDD patient 1 decrease of rapid facial reactions RFR to dynamic emotional faces expressing joy 2 increase of RFR to dynamic emotional faces expressing sadness 3 decrease of prosocial reaction after experimental social rejection
Secondary objective is to identify psychological and biological mediators We hypothetize in MDD patient 1mediating effect of systemic inflammatory cytokines an 2 mediating effect of state self esteem 30 MDD patients and 60 healthy subject will be included They will encounter psychiatric and psychometric evaluation Their facial EMG will be recorded to assess RFR to dynamic emotional faces created by photo morphing from KDEF emotional faces database coupled to occulometric recording Subjects will perform cyberball game as an experimental inclusion or exclusion task and the trustgame task as an implicit evaluation of their prosocial behavior Questionnaires will assess explicit measurement of social rejection pain and desire of affiliation Inflammatory markers will be measured in a blood sample before the cyberball task for every subjects and 6 hours later for 20 healthy volunteers Dosage of IL-6 IL-10 TNFa IP-10 MCP-1 MIP-1b Rantes sIL-6Ra IL1ra VEGF Leptin PECAM1 sTie2 sVEGFR1 sVEGFR2 will be performed by luminex technique and usCRP srIL2 ans sCD14 by ELISA technique
Recent neuroimaging data show that brain processing of social exclusion activate brain regions that are central to the pathophysiology of MDD Some of these regions are also known to be activated during physical pain and may contribute to the aversive dimension of the experienced rejection Pro-inflammatory cytokines are involved in MDD physiopathology and can induce social withdrawal behavior Inflammation can modulate social interactions in mammals Moreover after a social stress such as social rejection blood cytokines increase At a cognitive level self-esteem can modulate the sensitivity to social rejection
The major objective of the trial is to study sensitivity to social signals in MDD patient compared to healthy subject
The investigators hypothesize in MDD patient 1 decrease of rapid facial reactions RFR to dynamic emotional faces expressing joy 2 increase of RFR to dynamic emotional faces expressing sadness 3 decrease of prosocial reaction after experimental social rejection
Secondary objective is to identify psychological and biological mediators We hypothetize in MDD patient 1mediating effect of systemic inflammatory cytokines an 2 mediating effect of state self esteem 30 MDD patients and 60 healthy subject will be included They will encounter psychiatric and psychometric evaluation Their facial EMG will be recorded to assess RFR to dynamic emotional faces created by photo morphing from KDEF emotional faces database coupled to occulometric recording Subjects will perform cyberball game as an experimental inclusion or exclusion task and the trustgame task as an implicit evaluation of their prosocial behavior Questionnaires will assess explicit measurement of social rejection pain and desire of affiliation Inflammatory markers will be measured in a blood sample before the cyberball task for every subjects and 6 hours later for 20 healthy volunteers Dosage of IL-6 IL-10 TNFa IP-10 MCP-1 MIP-1b Rantes sIL-6Ra IL1ra VEGF Leptin PECAM1 sTie2 sVEGFR1 sVEGFR2 will be performed by luminex technique and usCRP srIL2 ans sCD14 by ELISA technique
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-A01484-41 | REGISTRY | ID-RCB | None |