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Plasma Beta-endorphin Levels and Suicidal Behavior (BEST)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Not yet enrolling

Conditions

Beta Endorphin
Depression
Suicide

Treatments

Other: questionnaires
Biological: Blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT06291467
RECHMPL23_0121

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Suicide attempters
Experimental group
Description:
patients hospitalized for suicide attempt within the last 72 hours
Treatment:
Biological: Blood samples
Other: questionnaires
Affective controls
Active Comparator group
Description:
patients hospitalized for current major depressive episode according to DSM-5 criteria and without any lifetime history of suicide attempt
Treatment:
Biological: Blood samples
Other: questionnaires

Trial contacts and locations

1

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Central trial contact

Bénédicte NOBILE, Pharm D, PhD; Philippe COURTET, MD PhD

Data sourced from clinicaltrials.gov

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