Clinical trial NCT06291467: Plasma Beta-endorphin Levels and Suicidal Behavior
Official title: Plasma Beta-endorphin Levels and Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Depression
Beta Endorphin
Keywords: suicide
depression
beta endorphin
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut de Génomique Fonctionnelle (IGF) de Montpellier
First posted: 2024-03-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* Common inclusion criteria:
* Aged between 18 and 65 years old,
* Subject with a psychiatric diagnosis of current major depressive episode according to DSM-5 criteria
* Able to understand the nature, purpose and methodology of the study

Specific inclusion criteria

* Suicide attempters: Subject hospitalized for of proven suicide attempt (\<72h)
* Affective controls: Subject hospitalized for a current major depressive episode according to DSM-5 criteria and without any lifetime history of suicidal behavior (proven, interrupted or aborted)

Non inclusion criteria

* Diagnosis of bipolar disorder
* Lifetime diagnosis of schizoaffective disorder, schizophrenia or unspecified psychosis
* Current diagnostic of illicit substance / alcohol use disorder within the last 6 months
* Diabetes or obesity (BMI \> 29)
* Inflammatory disease (e.g. Lupus, Rheumatoid Arthritis)
* Receiving opiate treatment or opiate substitution treatment
* Law protected ( guardianship or curatorship)
* Deprived of liberty (by judicial or administrative decision or forced hospitalization)
* Pregnant and breastfeeding women
* Inability to understand, speak and write French
* Refusal to participate in the study.
* Not be affiliated to a French National Social Security System

Primary outcomes:
measure: Comparison of plasma β-endorphin levels between patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any lifetime history of suicide attempt.
timeFrame: Baseline and day 7± 2 days
Secondary outcomes:
measure: - The kinetics of β-endorphin levels between two measurement points (inclusion and D7+/-2 days) in patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any history of suicide attempt.
timeFrame: Baseline and day 7± 2 days
measure: The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)
timeFrame: Baseline and day 7± 2 days
measure: The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)
timeFrame: Baseline and day 7± 2 days
measure: To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion,
timeFrame: Baseline and day 7± 2 days
measure: To assess the association between β-endorphin levels and Anhedonia
timeFrame: Baseline and day 7± 2 days
measure: To assess the association between β-endorphin levels and Current psychological and physical pain as well as usual and maximum over the 15 days before inclusion
timeFrame: Baseline and day 7± 2 days
measure: To assess the association between β-endorphin levels and Anxiety,
timeFrame: Baseline and day 7± 2 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Bénédicte NOBILE, Pharm D, PhD
role: STUDY_DIRECTOR
References: