Past Major Depressive EpisodeSUPHYNCT04714671
Social Stress and Suicide
A study testing The virtual version of the Social stress task : V-TSST in people with Past Major Depressive Episode and Euthymic, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Only vulnerable patients, when facing environmental stressors, attempt or commit suicide. Previous research demonstrated that suicide attempters usually misunderstand the social context and show impairments in decision making. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Past Major Depressive Episode, Euthymic
- What is being tested?
- The virtual version of the Social stress task : V-TSST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2021to 11 Feb 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- past major depressive episode according to the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
- euthymic (IDSC < 14 and YMRS < 7)
- ability to understand experimental procedures
- able to speak, read and understand French
- able to give written informed consent
- for suicide attempters only: Lifetime history of suicide attempt.
- for affective controls only: No lifetime history of suicide attempt
Who cannot join
- Lifetime diagnosis of schizoaffective disorder, schizophrenia or social phobia throughout
- Menopause
- Alcohol or illicit substance use disorder in the last 6 months;
- Diagnosis of current cardiovascular (arrhythmia, hypertension, heart valve problems, past heart attack or stroke, congenital heart disease), respiratory (chronic obstructive pulmonary disease, asthma, cystic fibrosis, tuberculosis, lung tumor) endocrine (adrenal disorder, cushing syndrome, adrenal tumor, type-2 diabetes, androgen deficiency, congenital adrenal hyperplasia, hypogonadism, polycystic ovarian syndrome) or neurological disease (dementia, brain stroke, epilepsia, multiple sclerosis, huntington disease, muscular dystrophy, brain or spinal cord tumor, meningitis) based on the first interview, which can interfere with the cardiovascular, endocrine or neurocognitive outcomes of the study;
- current cardiovascular medication which directly affects heart or arterial function or corticoids intake; anticoagulants, antiplatelet agents and dual antiplatelet therapy, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, angiotensin-receptor neprilysin inhibitors, beta blockers, calcium channel blockers, vasodilators.
- Pregnancy (urine pregnancy test) or breastfeeding
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- refusing to participate
- being in exclusion period for another study
- not being affiliated to the French National Social Security System
- having reached 4500€ annual compensation for participating to clinical trials
- being protected by law or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Social Stress in the Physiology and Cognition of Suicide Attempters: Heart Rate, Endocrine and Inflammatory Response, Decision Making
Only vulnerable patients, when facing environmental stressors, attempt or commit suicide. Previous research demonstrated that suicide attempters usually misunderstand the social context and show impairments in decision making. Heart activity, endocrine and inflammatory response to stress were related with these features. For that, suicide attempters, in a context of social stress, would have maladaptive physiological response impacting the following decision making. The main aim is to identify the physiological response (autonomous nervous system, endocrine and inflammatory response) of suicide attempters under social stress conditions and to investigate the association of this response with the posterior decision making.
The study aims to compare physiological response to social stress and posterior decision-making response in 80 euthymics women with a past mood disorder according to their history of suicide attempt
Read the detailed description
Hypothesis: 1. suicide attempters will have a lower cortisol, and, greater alpha-amylase and peripheral inflammatory response after a social stressor, compared to non-attempters 2. suicide attempters will have a hyper-activation of the cardiovascular response during the social stressor and a slower recovery to basal levels, compared with non-attempters.
- With respect to decision-making, suicide attempters will demonstrate riskier decision-making than non-attempters after the social stressor, compared to non-attempters. Risk-taking behavior will be related with lower cortisol and higher testosterone levels after the stressor.
Measures: electrocardiogram (ECG) and impedance cardiography (IKG) will be used to analyse cardiovascular function during social stressor. Salivary samples to analyze cortisol, testosterone and α-amylase. Blood samples to analyze several peripheral inflammatory proteins. The Iowa Gambling Task a neuropsychologial task to evaluate decision making. Several questionnaires of mood, anxiety and psychological pain during the stressor. And a comprehensive battery of clinical measures for screening and assessment of construct of suicide, and psychiatric and social status.
Procedures: Depressed females will be screened and assigned to 2 groups: 1) 40 depressed with suicide attempt history. 2) 40 depressed without suicide attempt history. Participants will confront a virtual version of the Trier Social Stress Test (V-TSST). This test consists in a preparation and execution of a presentation in front of a virtual tribunal for obtain a job position followed by an arithmetic mental task. During the procedure, ECG and IKG will be performed, 5 salivary samples and 5 blood samples (before and after the stressor) and some self-reports of mood, anxiety and pain. After procedure decision making will be assessed. Their participation will consist of 3 visits : inclusion visit (psychiatric interview), visit between 1 to 8 days (social stressor procedure), at 12 months (follow up).
Potential impact and next steps: Identifying differences between the two depressed groups in the physiological response to social stress and their subsequent decision making will advance the understanding of the pathophysiological mechanisms of suicide. As social stress is present in several life events during lifetime, know how suicidal people respond to these issues may help in the implementation of preventive interventions.
- Conditions
- Past Major Depressive Episode, Euthymic
- Being tested
- The virtual version of the Social stress task : V-TSST
- Keywords
- Suicide, Social stress, Cardiovascular, Decision making, Neuroendocrinology
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The virtual version of the Social stress task : V-TSSTOther
The task consists in a brief presentation about the abilities of participants followed by an arithmetic task in front of a virtual 3D audience projected and one researcher in a small room.First, participants have 5 minutes to prepare an exhibition about their qualities, their strengths and defects, and, why they identify with them. During this period virtual reality shows a closed curtain, and sounds from the audience can be heard. In the second phase, the curtain is raised and the participant must expose his speech during 5 minutes. Audience will remain attentive during 2 minutes, then audience will change to a restless attitude. The third phase consists of subtracting back a two-digit number from a four-digit number, as quickly as possible, starting again if participant makes a mistake. A debriefing of the test is scheduled at the end of the protocol, to remind patients of the purely fictional nature of this test. The visit will only end after a return to the baseline emotional state
| Study group | Role | What they receive |
|---|---|---|
| Euthymics patients with history of suicide attempt (suicide attempters) | Experimental | Euthymics patients with a lifetime history of suicide attempt will be evaluated using the Structured interview for psychiatric disorder; Columbia-Suicide severity rating scale; Inventory of Depressive Symptoms (IDSC); Young Mania Rating Scale (YMRS). Receives: Other: The virtual version of the Social stress task : V-TSST |
| Euthymics patients without any history of suicide attempt (affective controls) | Experimental | Euthymics patients without history of suicide attempt will be evaluated using the Structured interview for psychiatric disorder; Columbia-Suicide severity rating scale; Inventory of Depressive Symptoms (IDSC); Young Mania Rating Scale (YMRS). Receives: Other: The virtual version of the Social stress task : V-TSST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary cortisol
study of the change in salivary cortisol, across all procedure (from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST)
Measured: at visit between 1 to 8 days
Secondary outcomes (45)
Changes in cardiovascular response (heart rate)
study of the changes in heart rate (HR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (Cardiac output)
study of the changes in Cardiac output (CO) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (Total peripheral resistance)
study of the changes in Total peripheral resistance (TPR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response ((time between the two R peaks)
study of the changes in R-R interval (time between the two R peaks) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (pre-ejection period)
study of the changes in pre-ejection period (PEP) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response ( Vascular contractibility)
study of the changes in Vascular contractibility (VC) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (High frequency)
study of the changes in High frequency (HF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (Low frequency)
study of the changes in Low frequency (LF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (Very low frequency)
study of the changes in very Low frequency (VLF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in cardiovascular response (Root mean squared of successive R-R interval differences)
study of the changes in Root mean squared of successive R-R interval differences (RMSSD) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
Measured: at visit between 1 to 8 days
Changes in salivary testosterone
Study of the changes in salivary testosterone, after V-TSST, from -10 to +15, +30, +45 and +60 minutes following the completion fo V-TSST
Measured: at visit between 1 to 8 days
Changes in salivary α-amylase
Study of the changes in salivary α-amylase, after V-TSST, from -10 to +15, +30, +45 and +60 minutes following the completion fo V-TSST
Measured: at visit between 1 to 8 days
Risk Taking decision making after V-TSST
risk-taking using Iowa Gambling (IG) index from Iowa Gambling Task (IGT)
Measured: at visit between 1 to 8 days
Sense of fairness/unfairness after V-TSST
Using the total score of Ultimatum
Measured: at visit between 1 to 8 days
Domination/submission after V-TSST
Using the total score of Hawk and Dove game. The score ranges from 0 to 24, a higher score indicates the most dominant
Measured: at visit between 1 to 8 days
Changes in anxiety level induced by V-TSST
Changes in psychometric state measures : anxiety using the state anxiety inventory, after V-TSST, from -10 to + 15, + 60 and + 120 minutes post V-TSST
Measured: at visit between 1 to 8 days
Changes in depression level induced by V-TSST
Changes in psychometric state measures : mood using the Positive and Negative Affect Schedule, after V-TSST, from baseline to + 15, + 60 and + 120 minutes post V-TSST
Measured: at visit between 1 to 8 days
Changes in psychological pain level induced by V-TSST
Changes in psychometric state measures : psychological pain using a visual analogue scale, after V-TSST, from baseline to + 15, + 60 and + 120 post V-TSST. The score ranges from 0 to 10, a higher score indicates the most important psychological pain
Measured: at inclusion
Changes in suicidal ideation level induced by V-TSST
Changes in psychometric state measures : suicidal ideation using a visual analogue scale, after V-TSST, from baseline to + 15, + 60 and + 120 post V-TSST. SST. The score ranges from 0 to 10, a higher score indicates the most important suicidal ideation
Measured: at visit between 1 to 8 days
Changes in social distress level induced by V-TSST
Changes in psychometric state measures : social distress using a visual analogue scale, after V-TSST, from -10 to + 15, + 60 and + 120 minutes post V-TSST. The score ranges from 0 to 10, a higher score indicates the most important social distress
Measured: at visit between 1 to 8 days
Changes in C-Reactive Protein (CRP) induced by V-TSST
Study of the changes in CRP, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Interleukin (IL) - 1b induced by V-TSST
Study of the changes in IL-1b, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL-6 induced by V-TSST
Study of the changes in IL-6, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL1β induced by V-TSST
Study of the changes in IL1β, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL2 induced by V-TSST
Study of the changes in IL2, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL4 induced by V-TSST
Study of the changes in IL4, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL8 induced by V-TSST
Study of the changes in IL8, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL10 induced by V-TSST
Study of the changes in IL10, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL13 induced by V-TSST
Study of the changes in IL13, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IL27 induced by V-TSST
Study of the changes in IL27, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in NF-KB protein induced by V-TSST
Study of the changes in NF-KB protein, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in IKB protein induced by V-TSST
Study of the changes in IKB protein, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST
Study of the changes in TNF-α, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Interferon (IFN) - γ induced by V-TSST
Study of the changes in IFN-γ, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST
Study of the changes in VEGF, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in kyrunenine induced by V-TSST
Study of the changes in kyrunenine, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in sCD62P induced by V-TSST
Study of the changes in sCD62P, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in sCD40L induced by V-TSST
Study of the changes in sCD40L, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Platelet factor (PF) 4 induced by V-TSST
Study of the changes in PF4, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in RANTES induced by V-TSST
Study of the changes in RANTES, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST
Study of the changes in BDNF, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in sOx40L induced by V-TSST
Study of the changes in sOx40L, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Microparticle induced by V-TSST
Study of the changes in Microparticle, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Changes in Mitochondrial deoxyribonucleic acid (DNA) of platelet origin induced by V-TSST
Study of the changes in Mitochondrial DNA of platelet origin, after the V-TSST, from -10 to +15, +60, +90 and +120 minutes following the completion post V-TSST.
Measured: at visit between 1 to 8 days
Suicidal behavior evaluated with the C-SSRS
Measured: at 12 months post V-SST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start27 Jan 2021
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Past Major Depressive EpisodeStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714671
- Sponsor's protocol ID
- RECHMPL20_0413
- Other IDs
- 2020-A03045-34
- Acronym
- SUPHY
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2020
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Social Stress in the Physiology and Cognition of Suicide Attempters: Heart Rate, Endocrine and Inflammatory Response, Decision Making
- ClinicalTrials.gov ID
- NCT04714671
- Acronym / sponsor ID
- SUPHY / RECHMPL20_0413
- Conditions
- Past Major Depressive Episode, Euthymic
- Keywords
- Suicide, Social stress, Cardiovascular, Decision making, Neuroendocrinology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 19 Jan 2021 (actual)
- 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.
Only vulnerable patients, when facing environmental stressors, attempt or commit suicide. Previous research demonstrated that suicide attempters usually misunderstand the social context and show impairments in decision making. Heart activity, endocrine and inflammatory response to stress were related with these features. For that, suicide attempters, in a context of social stress, would have maladaptive physiological response impacting the following decision making. The main aim is to identify the physiological response (autonomous nervous system, endocrine and inflammatory response) of suicide attempters under social stress conditions and to investigate the association of this response with the posterior decision making.
The study aims to compare physiological response to social stress and posterior decision-making response in 80 euthymics women with a past mood disorder according to their history of suicide attempt
Detailed description
Hypothesis: 1. suicide attempters will have a lower cortisol, and, greater alpha-amylase and peripheral inflammatory response after a social stressor, compared to non-attempters 2. suicide attempters will have a hyper-activation of the cardiovascular response during the social stressor and a slower recovery to basal levels, compared with non-attempters.
- With respect to decision-making, suicide attempters will demonstrate riskier decision-making than non-attempters after the social stressor, compared to non-attempters. Risk-taking behavior will be related with lower cortisol and higher testosterone levels after the stressor.
Measures: electrocardiogram (ECG) and impedance cardiography (IKG) will be used to analyse cardiovascular function during social stressor. Salivary samples to analyze cortisol, testosterone and α-amylase. Blood samples to analyze several peripheral inflammatory proteins. The Iowa Gambling Task a neuropsychologial task to evaluate decision making. Several questionnaires of mood, anxiety and psychological pain during the stressor. And a comprehensive battery of clinical measures for screening and assessment of construct of suicide, and psychiatric and social status.
Procedures: Depressed females will be screened and assigned to 2 groups: 1) 40 depressed with suicide attempt history. 2) 40 depressed without suicide attempt history. Participants will confront a virtual version of the Trier Social Stress Test (V-TSST). This test consists in a preparation and execution of a presentation in front of a virtual tribunal for obtain a job position followed by an arithmetic mental task. During the procedure, ECG and IKG will be performed, 5 salivary samples and 5 blood samples (before and after the stressor) and some self-reports of mood, anxiety and pain. After procedure decision making will be assessed. Their participation will consist of 3 visits : inclusion visit (psychiatric interview), visit between 1 to 8 days (social stressor procedure), at 12 months (follow up).
Potential impact and next steps: Identifying differences between the two depressed groups in the physiological response to social stress and their subsequent decision making will advance the understanding of the pathophysiological mechanisms of suicide. As social stress is present in several life events during lifetime, know how suicidal people respond to these issues may help in the implementation of preventive interventions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Euthymics patients with history of suicide attempt (suicide attempters) | Experimental | Other: The virtual version of the Social stress task : V-TSSTEuthymics patients with a lifetime history of suicide attempt will be evaluated using the Structured interview for psychiatric disorder; Columbia-Suicide severity rating scale; Inventory of Depressive Symptoms (IDSC); Young Mania Rating Scale (YMRS). |
| Euthymics patients without any history of suicide attempt (affective controls) | Experimental | Other: The virtual version of the Social stress task : V-TSSTEuthymics patients without history of suicide attempt will be evaluated using the Structured interview for psychiatric disorder; Columbia-Suicide severity rating scale; Inventory of Depressive Symptoms (IDSC); Young Mania Rating Scale (YMRS). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- past major depressive episode according to the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)
- euthymic (IDSC < 14 and YMRS < 7)
- ability to understand experimental procedures
- able to speak, read and understand French
- able to give written informed consent
Key exclusion criteria (11 listed)
- Lifetime diagnosis of schizoaffective disorder, schizophrenia or social phobia throughout
- Menopause
- Alcohol or illicit substance use disorder in the last 6 months;
- Diagnosis of current cardiovascular (arrhythmia, hypertension, heart valve problems, past heart attack or stroke, congenital heart disease), respiratory (chronic obstructive pulmonary disease, asthma, cystic fibrosis, tuberculosis, lung tumor) endocrine (adrenal disorder, cushing syndrome, adrenal tumor, type-2 diabetes, androgen deficiency, congenital adrenal hyperplasia, hypogonadism, polycystic ovarian syndrome) or neurological disease (dementia, brain stroke, epilepsia, multiple sclerosis, huntington disease, muscular dystrophy, brain or spinal cord tumor, meningitis) based on the first interview, which can interfere with the cardiovascular, endocrine or neurocognitive outcomes of the study;
- current cardiovascular medication which directly affects heart or arterial function or corticoids intake; anticoagulants, antiplatelet agents and dual antiplatelet therapy, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, angiotensin-receptor neprilysin inhibitors, beta blockers, calcium channel blockers, vasodilators.
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 |
|---|---|---|
| The virtual version of the Social stress task : V-TSSTThe task consists in a brief presentation about the abilities of participants followed by an arithmetic task in front of a virtual 3D audience projected and one researcher in a small room.First, participants have 5 minutes to prepare an exhibition about their qualities, their strengths and defects, and, why they identify with them. During this period virtual reality shows a closed curtain, and sounds from the audience can be heard. In the second phase, the curtain is raised and the participant must expose his speech during 5 minutes. Audience will remain attentive during 2 minutes, then audience will change to a restless attitude. The third phase consists of subtracting back a two-digit number from a four-digit number, as quickly as possible, starting again if participant makes a mistake. A debriefing of the test is scheduled at the end of the protocol, to remind patients of the purely fictional nature of this test. The visit will only end after a return to the baseline emotional state | Other | Euthymics patients with history of suicide attempt (suicide attempters), Euthymics patients without any history of suicide attempt (affective controls) |
Primary outcome
Change in salivary cortisol
Time frame: at visit between 1 to 8 days
study of the change in salivary cortisol, across all procedure (from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST)
45 secondary outcomes
Changes in cardiovascular response (heart rate)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (Cardiac output)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (Total peripheral resistance)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response ((time between the two R peaks)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (pre-ejection period)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response ( Vascular contractibility)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (High frequency)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (Low frequency)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (Very low frequency)
Time frame: at visit between 1 to 8 days
Changes in cardiovascular response (Root mean squared of successive R-R interval differences)
Time frame: at visit between 1 to 8 days
Changes in salivary testosterone
Time frame: at visit between 1 to 8 days
Changes in salivary α-amylase
Time frame: at visit between 1 to 8 days
Risk Taking decision making after V-TSST
Time frame: at visit between 1 to 8 days
Sense of fairness/unfairness after V-TSST
Time frame: at visit between 1 to 8 days
Domination/submission after V-TSST
Time frame: at visit between 1 to 8 days
Changes in anxiety level induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in depression level induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in psychological pain level induced by V-TSST
Time frame: at inclusion
Changes in suicidal ideation level induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in social distress level induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in C-Reactive Protein (CRP) induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in Interleukin (IL) - 1b induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL-6 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL1β induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL2 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL4 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL8 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL10 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL13 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IL27 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in NF-KB protein induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in IKB protein induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in Interferon (IFN) - γ induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in kyrunenine induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in sCD62P induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in sCD40L induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in Platelet factor (PF) 4 induced by V-TSST
Time frame: at visit between 1 to 8 days
Changes in RANTES induced by V-TSST
Time frame: at visit between 1 to 8 days
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 19 Feb 2025.
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?
A study testing The virtual version of the Social stress task : V-TSST in people with Past Major Depressive Episode and Euthymic, 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 7 inclusion and 11 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 19 Feb 2025. 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?
Change in salivary cortisol (time frame: at visit between 1 to 8 days). 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 19 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.