Plasma Beta-endorphin Levels and Suicidal Behavior

NCT06291467 | Not Yet Recruiting

• 1 other identifier: RECHMPL23_0121
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Depression; Beta Endorphin

Keywords

suicide; depression; beta endorphin

Outcome Measures

Primary Outcomes (1)

• 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.

  blood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)

  Baseline and day 7± 2 days

Secondary Outcomes (7)

• - 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 days

• The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)

  Baseline and day 7± 2 days

• The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)

  Baseline and day 7± 2 days

• 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 days

• To assess the association between β-endorphin levels and Anhedonia

  Baseline and day 7± 2 days

Study Arms (2)

Suicide attempters

EXPERIMENTAL

patients hospitalized for suicide attempt within the last 72 hours

Biological: Blood samples; Other: questionnaires

Affective controls

ACTIVE COMPARATOR

patients hospitalized for current major depressive episode according to DSM-5 criteria and without any lifetime history of suicide attempt

Biological: Blood samples; Other: questionnaires

Interventions

Blood samples BIOLOGICAL

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

Affective controls; Suicide attempters

questionnaires OTHER

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)

Affective controls; Suicide attempters

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut de Génomique Fonctionnelle (IGF) de Montpellier: collaborator

Study Sites (1)

University hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Suicide; Depression

Interventions

Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Bénédicte NOBILE, Pharm D, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Bénédicte NOBILE, Pharm D, PhD

CONTACT

33 (0)4 99 61 46 93; b-nobile@chu-montpellier.fr

Philippe COURTET, MD PhD

CONTACT

+33467338581; p-courtet@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)