Social Stress and Suicide (SUPHY)
31 de diciembre de 2021 actualizado por: University Hospital, Montpellier
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
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
3. 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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
80
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Philippe COURTET, MD PhD
- Número de teléfono: +33 4 67 33 85 81
- Correo electrónico: p-courtet@chu-montpellier.fr
Ubicaciones de estudio
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Hérault
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Montpellier, Hérault, Francia, 34295
- Reclutamiento
- University Hospital, Montpellier
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Contacto:
- Philippe COURTET, MD PhD
- Número de teléfono: +33 4 67 33 85 81
- Correo electrónico: p-courtet@chu-montpellier.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Euthymics patients with history of suicide attempt (suicide attempters)
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).
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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
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Experimental: Euthymics patients without any history of suicide attempt (affective controls)
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).
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in salivary cortisol
Periodo de tiempo: at visit between 1 to 8 days
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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)
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at visit between 1 to 8 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in cardiovascular response (heart rate)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in heart rate (HR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response (Cardiac output)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in Cardiac output (CO) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response (Total peripheral resistance)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in Total peripheral resistance (TPR) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response ((time between the two R peaks)
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in cardiovascular response (pre-ejection period)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in pre-ejection period (PEP) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response ( Vascular contractibility)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in Vascular contractibility (VC) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response (High frequency)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in High frequency (HF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response (Low frequency)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in Low frequency (LF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response (Very low frequency)
Periodo de tiempo: at visit between 1 to 8 days
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study of the changes in very Low frequency (VLF) from -10 to +15, +30, +45 and +60 minutes following the completion of V-TSST.
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at visit between 1 to 8 days
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Changes in cardiovascular response (Root mean squared of successive R-R interval differences)
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in salivary testosterone
Periodo de tiempo: at visit between 1 to 8 days
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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
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at visit between 1 to 8 days
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Changes in salivary α-amylase
Periodo de tiempo: at visit between 1 to 8 days
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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
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at visit between 1 to 8 days
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Risk Taking decision making after V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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risk-taking using Iowa Gambling (IG) index from Iowa Gambling Task (IGT)
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at visit between 1 to 8 days
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Sense of fairness/unfairness after V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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Using the total score of Ultimatum
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at visit between 1 to 8 days
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Domination/submission after V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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Using the total score of Hawk and Dove game.
The score ranges from 0 to 24, a higher score indicates the most dominant
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at visit between 1 to 8 days
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Changes in anxiety level induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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
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at visit between 1 to 8 days
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Changes in depression level induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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
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at visit between 1 to 8 days
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Changes in psychological pain level induced by V-TSST
Periodo de tiempo: at inclusion
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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
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at inclusion
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Changes in suicidal ideation level induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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
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at visit between 1 to 8 days
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Changes in social distress level induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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
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at visit between 1 to 8 days
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Changes in C-Reactive Protein (CRP) induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in Interleukin (IL) - 1b induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL-6 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL1β induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL2 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL4 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL8 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL10 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL13 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IL27 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in NF-KB protein induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in IKB protein induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
|
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.
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at visit between 1 to 8 days
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Changes in Tumor necrosis factor (TNF) - α protein induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in Interferon (IFN) - γ induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in Vascular endothelial growth factor (VEGF) induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in kyrunenine induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
|
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.
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at visit between 1 to 8 days
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Changes in sCD62P induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in sCD40L induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in Platelet factor (PF) 4 induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in RANTES induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in Brain derived neurotrophic factor (BDNF) induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in sOx40L induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
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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.
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at visit between 1 to 8 days
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Changes in Microparticle induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
|
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.
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at visit between 1 to 8 days
|
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Changes in Mitochondrial deoxyribonucleic acid (DNA) of platelet origin induced by V-TSST
Periodo de tiempo: at visit between 1 to 8 days
|
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.
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at visit between 1 to 8 days
|
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Suicidal behavior evaluated with the C-SSRS
Periodo de tiempo: at 12 months post V-SST
|
at 12 months post V-SST
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de enero de 2021
Finalización primaria (Anticipado)
1 de enero de 2022
Finalización del estudio (Anticipado)
1 de enero de 2024
Fechas de registro del estudio
Enviado por primera vez
21 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
15 de enero de 2021
Publicado por primera vez (Actual)
19 de enero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
31 de diciembre de 2021
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RECHMPL20_0413
- 2020-A03045-34 (Otro identificador: ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .