Plasma Beta-endorphin Levels and Suicidal Behavior

Depression Clinical Trial

— BEST  

Official title:

Plasma Beta-endorphin Levels and Suicidal Behavior

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06291467
• Other study ID #: RECHMPL23_0121
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Bénédicte NOBILE, Pharm D, PhD
• Phone: 33 (0)4 99 61 46 93
• Email: b-nobile[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Suicide

Intervention

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

Other:
• questionnaires
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)

Locations

Country	Name	City	State
France	University hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut de Génomique Fonctionnelle (IGF) de Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of plasma ß-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 ß-endorphin dosage (pg/mL)	Baseline and day 7± 2 days
Secondary	- The kinetics of ß-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.	blood sample between 8:30 a.m. and 9:30 a.m for ß-endorphin dosage (pg/mL)	Baseline and day 7± 2 days
Secondary	The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)	MADRS (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) .	Baseline and day 7± 2 days
Secondary	The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)	the 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).	Baseline and day 7± 2 days
Secondary	To assess the association between ß-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion,	Assessed 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)	Baseline and day 7± 2 days
Secondary	To assess the association between ß-endorphin levels and Anhedonia	assessed 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)	Baseline and day 7± 2 days
Secondary	To assess the association between ß-endorphin levels and Current psychological and physical pain as well as usual and maximum over the 15 days before inclusion	assessed 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.	Baseline and day 7± 2 days
Secondary	To assess the association between ß-endorphin levels and Anxiety,	Assessed 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.	Baseline and day 7± 2 days