Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 7:07 AM
Study NCT ID:
NCT06291467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Beta-endorphin Levels and Suicidal Behavior
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Plasma Beta-endorphin Levels and Suicidal Behavior
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
BEST
Brief Summary:
It is an interventional research, monocentric, which involves only minimal risks and constraints.
Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.
The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.
The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA.
Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.
The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.
The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA.
Detailed Description:
104 participants will be enrolled, divided into 2 groups:
group 1: 52 Suicide attempters, currently hospitalized patients for a suicide attempt within the 72 last hours group 2: 50 Affective controls, currently hospitalized patients for current major depressive episode according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and without any lifetime history of suicide attempt;
The protocol includes two visits.The first visit is the inclusion visit carried out at the beginning of patient hospitalization, within 72 hours following suicide attempt (SA) for group 1 (suicide attempters) and within 72 hours following the admission to hospital for group 2 (affective controls).
The second visit takes place at the end of hospitalisation, on Day 7 +/- 2 days, after SA for group 1 and after admission to hospital for group 2 .
At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure beta-β-endorphin levels.
group 1: 52 Suicide attempters, currently hospitalized patients for a suicide attempt within the 72 last hours group 2: 50 Affective controls, currently hospitalized patients for current major depressive episode according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and without any lifetime history of suicide attempt;
The protocol includes two visits.The first visit is the inclusion visit carried out at the beginning of patient hospitalization, within 72 hours following suicide attempt (SA) for group 1 (suicide attempters) and within 72 hours following the admission to hospital for group 2 (affective controls).
The second visit takes place at the end of hospitalisation, on Day 7 +/- 2 days, after SA for group 1 and after admission to hospital for group 2 .
At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure beta-β-endorphin levels.
Study Oversight
Has Oversight DMC:
False
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?: