Major Depressive DisorderSENSONCT02214511
Biomarkers of Social Sensitivity in Major Depression
An observational study of Major Depressive Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- emotional facial stimuli and Cyberball game
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2014to 1 Mar 2017
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. st group : major depression disorder patients 2. nd group : healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude de la sensibilité Aux Signaux Sociaux Dans la dépression, Modulateurs Psychologiques, Comportementaux et Inflammatoires.
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.
Read more
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.
- Conditions
- Major Depressive Disorder
- Being tested
- emotional facial stimuli, Cyberball game
- Keywords
- major depressive disorder, social rejection, rapid facial reaction, facial mimicry, prosocial behavior, inflammation, self esteem
- Medical subject headings
- Depressive Disorder, Major, Social Isolation, Altruism, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional facial stimuliBehavioural
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.
Cyberball gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MDD patients | emotional facial stimuli cyberball game Receives: Behavioral: emotional facial stimuli; Behavioral: Cyberball game | |
| healthy subjects | emotional facial stimuli cyberball game Receives: Behavioral: emotional facial stimuli; Behavioral: Cyberball game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid facial reactions : milliVolts amplitude of electromyographic signal of zygomaticus, corrugator, depressor & frontalis muscles
During passive watching of dynamic emotional faces, electromyographic signal is recorded with skin electrodes facing zygomaticus, corrugator, depressor \& frontalis muscles.
Measured: During stimuli presentation (emotional faces) at Day 1 from 9:40 to 10:30 am
Implicit pro-social behavior : invested money during a 4-round trust game
Total amount of money invested by the subject during a 4-round trust game without feedback.
Measured: At Day 1 from 11:40 to 11:50 am
Explicit pro-social behavior : affiliation desire measured by a questionnaire
Affiliation desire questionnaire from Park and Manner assessing total affiliation desire and affiliation desire towards close relationship or strangers.
Measured: At Day 1 from 11:50 to 12:00 am
Secondary outcomes (2)
Self esteem assessed by questionnaires mediates social pain after rejection and pro-social behavior
Scoring of questionnaires of state and trait self esteem (state self esteem scale and Rosenberg scale)
Measured: 2 assessments at Day 1 : at 8:30 and at 11:50 am
Systemic inflammation mediates social pain after rejection and pro-social behavior
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.
Measured: At day 1 : at 11:30 am and 5:30 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study start23 Oct 2014
- Primary completionMar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214511
- Sponsor's protocol ID
- C13-31
- Other IDs
- 2013-A01484-41
- Acronym
- SENSO
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2014
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude de la sensibilité Aux Signaux Sociaux Dans la dépression, Modulateurs Psychologiques, Comportementaux et Inflammatoires.
- ClinicalTrials.gov ID
- NCT02214511
- Acronym / sponsor ID
- SENSO / C13-31
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, social rejection, rapid facial reaction, facial mimicry, prosocial behavior, inflammation, self esteem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 12 Aug 2014 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD patients | – | Behavioral: emotional facial stimuli, Behavioral: Cyberball gameemotional facial stimuli cyberball game |
| healthy subjects | – | Behavioral: emotional facial stimuli, Behavioral: Cyberball gameemotional facial stimuli cyberball game |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. st group : major depression disorder patients 2. nd group : healthy volunteers
Key inclusion criteria (8 listed)
- benefit social health insurance
- french speaker and reader
- can stop smoking one day
- volunteer to participate
- actual MDD diagnosed by a psychiatrist and meet the DSM IV criterias of MDD
Key exclusion criteria (17 listed)
- BMI > 40
- weekly sport > 3 hours
- pregnancy
- fever or other infection symptoms during the last month
- significant or unstable disease, especially neurologic or inflammatory.
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 |
|---|---|---|
| emotional facial stimuliSubjects 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. | Behavioural | MDD patients, healthy subjects |
| Cyberball gameBall tossing computer game to manipulate social inclusion status : rejection or inclusion. Social behavior, social pain and inflammatory modification will be assessed after the game. | Behavioural | MDD patients, healthy subjects |
Primary outcome
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.
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.
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.
2 secondary outcomes
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
Systemic inflammation mediates social pain after rejection and pro-social behavior
Time frame: At day 1 : at 11:30 am and 5:30 pm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Institut National de la Santé Et de la Recherche Médicale, France 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 30 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. 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 30 Aug 2021.