Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714671
Status:
UNKNOWN
Last Update Posted:
2022-01-04
First Post:
2020-12-21
Brief Title:
Social Stress and Suicide
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Effect of Social Stress in the Physiology and Cognition of Suicide Attempters Heart Rate Endocrine and Inflammatory Response Decision Making
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPHY
Brief 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 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-A03045-34 | OTHER | ANSM | None |