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Plasma Beta-endorphin Levels and Suicidal Behavior

Plasma Beta-endorphin Levels and Suicidal Behavior

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06291467
Acronym
BEST
Enrollment
104
Registered
2024-03-04
Start date
2024-03-31
Completion date
2026-03-31
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Endorphin, Depression, Suicide

Keywords

suicide, depression, beta endorphin

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.

Interventions

BIOLOGICALBlood samples

Blood samples will be collected at both visit between 8:30 a.m. and 9:30 a.m. and fasting from midnight.

OTHERquestionnaires

Questionnaires will be administrated at both visits to assess the suicide spectrum, the depression level and some personality traits. Hetero-questionnaires will be administrated during a clinical interview conducted by a psychiatrist or psychologist at the inclusion. * MINI 7.0 Mini-International Neuropsychiatric Interview : * MADRS (Montgomery Asberg Depression Scale) * C-SSRS (Columbia-Suicide Severity Rating Scale) * FAST (Functioning Assessment Short Test) Self-administered questionnaire will be completed by the participant at the inclusion and at the end of hospitalisation (D7+/- 2 days) : * STAI-Y (State-Trait Anxiety Inventory ) * PPP-VAS (Visual Analog Scale to measure Psychological and Physical Pain) * SHAPS (Snaith-Hamilton-Pleasure Scale ) * CTQ (Childhood Trauma Questionnaire) * ESUL : Echelle de solitude de l'université de Laval * BIS-11 : (Barratt Impulsiveness Scale) * QIDS (Quick Inventory of Depressive Symptomatology)

Sponsors

Institut de Génomique Fonctionnelle (IGF) de Montpellier
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.Baseline and day 7± 2 daysblood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)

Secondary

MeasureTime frameDescription
- 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.Baseline and day 7± 2 daysblood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)
The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)Baseline and day 7± 2 daysMADRS (Montgomery and Asberg Depression Rating Scale, hetero-assessment) is a 10-item questionnaire with a score ranging from 0 to 60 (the higher the score, the more depressive symptoms are present) .
The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)Baseline and day 7± 2 daysthe QIDS-16 (Quick Inventory of Depressive Symptomatology, self-questionnaire) is a 16 items questionnaire, scored from 0 to 3,The total score ranges from 0 (no depression) to 42 (severe depression).
To assess the association between β-endorphin levels and AnhedoniaBaseline and day 7± 2 daysassessed with the SHAPS (Snaith and Hamilton pleasure scale, self-assessment)14 items scoring 0 to 3 for each item (the lower the score, the lower the pleasure)
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 inclusionBaseline and day 7± 2 daysassessed with a numerical scale (Visual Analog Scale to measure Psychological and Physical Pain : PPP-VAS, self-questionnaire scoring 0 to 10, the lower the score, the less pain.
To assess the association between β-endorphin levels and Anxiety,Baseline and day 7± 2 daysAssessed with the STAI (trait and state anxiety assessment scale, self-questionnaire) composed of 2 distinctive scale. Each consists of 20 items rated from 0 to 3.
To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion,Baseline and day 7± 2 daysAssessed with the CSSRS (Columbia Suicide Severity Rating Scale, hetero-assessment) questionnaire used for suicide assessment with a scale from 0 to 5 (highest suicidal risk)

Countries

France

Contacts

Primary ContactBénédicte NOBILE, Pharm D, PhD
b-nobile@chu-montpellier.fr33 (0)4 99 61 46 93
Backup ContactPhilippe COURTET, MD PhD
p-courtet@chu-montpellier.fr+33467338581

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026