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Biomarkers of Social Sensitivity in Major Depression (SENSO)

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ClinicalTrials.gov Identifier: NCT02214511
Recruitment Status : Unknown
Verified June 2014 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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: (1)mediating 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.


Condition or disease Intervention/treatment
Major Depressive Disorder Behavioral: emotional facial stimuli Behavioral: Cyberball game

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etude de la sensibilité Aux Signaux Sociaux Dans la dépression, Modulateurs Psychologiques, Comportementaux et Inflammatoires.
Study Start Date : July 2014
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MDD patients
emotional facial stimuli cyberball game
Behavioral: emotional facial stimuli
Subjects watch passively dynamic facial emotions obtained by emotionnal faces photos morphing. Their rapid facial reactions are recorded by faciel EMG device as eye movement by occulometric device.

Behavioral: Cyberball game
Ball tossing computer game to manipulate social inclusion status : rejection or inclusion. Social behavior, social pain and inflammatory modification will be assessed after the game.

healthy subjects
emotional facial stimuli cyberball game
Behavioral: emotional facial stimuli
Subjects watch passively dynamic facial emotions obtained by emotionnal faces photos morphing. Their rapid facial reactions are recorded by faciel EMG device as eye movement by occulometric device.

Behavioral: Cyberball game
Ball tossing computer game to manipulate social inclusion status : rejection or inclusion. Social behavior, social pain and inflammatory modification will be assessed after the game.




Primary Outcome Measures :
  1. Rapid facial reactions : milliVolts amplitude of electromyographic signal of zygomaticus, corrugator, depressor & frontalis muscles [ Time Frame: During stimuli presentation (emotional faces) at Day 1 from 9:40 to 10:30 am ]
    During passive watching of dynamic emotional faces, electromyographic signal is recorded with skin electrodes facing zygomaticus, corrugator, depressor & frontalis muscles.

  2. Implicit pro-social behavior : invested money during a 4-round trust game [ Time Frame: At Day 1 from 11:40 to 11:50 am ]
    Total amount of money invested by the subject during a 4-round trust game without feedback.

  3. Explicit pro-social behavior : affiliation desire measured by a questionnaire [ Time Frame: At Day 1 from 11:50 to 12:00 am ]
    Affiliation desire questionnaire from Park and Manner assessing total affiliation desire and affiliation desire towards close relationship or strangers.


Secondary Outcome Measures :
  1. Self esteem assessed by questionnaires mediates social pain after rejection and pro-social behavior [ Time Frame: 2 assessments at Day 1 : at 8:30 and at 11:50 am ]
    Scoring of questionnaires of state and trait self esteem (state self esteem scale and Rosenberg scale)

  2. Systemic inflammation mediates social pain after rejection and pro-social behavior [ Time Frame: At day 1 : at 11:30 am and 5:30 pm ]

    Inflammatory dosage in blood :

    • IL-6, IL-10, TNFa, IP-10, MCP-1, MIP-1b, Rantes, sIL-6Ra, IL1ra, VEGF, Leptin, PECAM1, sTie2, sVEGFR1, sVEGFR2 by luminex technique
    • usCRP, srIL2 ans sCD14 by ELISA technique.


Biospecimen Retention:   Samples With DNA
Blood samples to explore inflammatory cytokines. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. st group : major depression disorder patients
  2. nd group : healthy volunteers
Criteria

Inclusion Criteria:

For everybody :

  • benefit social health insurance
  • french speaker and reader
  • can stop smoking one day
  • volunteer to participate

For 1st group :

  • actual MDD diagnosed by a psychiatrist and meet the DSM IV criterias of MDD
  • no antidepressant treatment or antidepressant treatment for less than 7 days.

Exclusion Criteria:

  • BMI > 40
  • weekly sport > 3 hours
  • pregnancy
  • fever or other infection symptoms during the last month
  • significant or unstable disease, especially neurologic or inflammatory.
  • recent history of coronary disease, ulcer, COPD, severe dyslipemia, kidney or liver failure.
  • severe smoking addiction (fagerström > 8)
  • antiinflammatory or immunomodulatory treatment during last month

For 1st group :

  • no psychiatric treatment except benzodiazepin if no severe vigilance trouble and antidepressant treatment more than 7 days
  • subjects under legal protection
  • constraint hospitalization
  • significant suicidal risk
  • resistant MDD
  • psychiatric comorbidity

For 2nd group :

- psychiatric disease, actual or past according to DSM IV criterias


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214511


Locations
France
ICM, Pitié Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02214511     History of Changes
Other Study ID Numbers: C13-31
2013-A01484-41 ( Registry Identifier: ID-RCB )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: June 2014

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
major depressive disorder
social rejection
rapid facial reaction
facial mimicry
prosocial behavior
inflammation
self esteem

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders