SuicideBESTNCT06291467
Plasma Beta-endorphin Levels and Suicidal Behavior
A study testing Blood samples and questionnaires in people with Suicide and Depression, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Depression, Beta Endorphin
- What is being tested?
- Blood samples and questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 20Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
University hospital
Montpellier, 34295
Jessica DALAUDIERE, jessica.dalaudiere@chu-montpellier.fr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Suicide, Depression, Beta Endorphin
- Being tested
- Blood samples, questionnaires
- Keywords
- suicide, depression, beta endorphin
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
Blood samples will be collected at both visit between 8:30 a.m. and 9:30 a.m. and fasting from midnight.
questionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Suicide attempters | Experimental | patients hospitalized for suicide attempt within the last 72 hours Receives: 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 Receives: Biological: Blood samples; Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
blood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)
Measured: Baseline and day 7± 2 days
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) .
Measured: Baseline and day 7± 2 days
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).
Measured: 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,
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)
Measured: Baseline and day 7± 2 days
To assess the association between β-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)
Measured: Baseline and day 7± 2 days
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
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.
Measured: Baseline and day 7± 2 days
To assess the association between β-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.
Measured: Baseline and day 7± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Génomique Fonctionnelle (IGF) de Montpellier
- Responsible party
- Sponsor
- Investigators
- Bénédicte NOBILE, Pharm D, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291467
- Sponsor's protocol ID
- RECHMPL23_0121
- Acronym
- BEST
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Beta-endorphin Levels and Suicidal Behavior
- ClinicalTrials.gov ID
- NCT06291467
- Acronym / sponsor ID
- BEST / RECHMPL23_0121
- Conditions
- Suicide, Depression, Beta Endorphin
- Keywords
- suicide, depression, beta endorphin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut de Génomique Fonctionnelle (IGF) de Montpellier
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicide attempters | Experimental | Biological: Blood samples, Other: questionnairespatients hospitalized for suicide attempt within the last 72 hours |
| Affective controls | Active comparator | Biological: Blood samples, Other: questionnairespatients hospitalized for current major depressive episode according to DSM-5 criteria and without any lifetime history of suicide attempt |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood samples will be collected at both visit between 8:30 a.m. and 9:30 a.m. and fasting from midnight. | Biological | Affective controls, Suicide attempters |
| questionnairesQuestionnaires 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) | Other | Affective controls, Suicide attempters |
Primary outcome
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.
Time frame: Baseline and day 7± 2 days
blood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)
7 secondary outcomes
- 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.
Time frame: Baseline and day 7± 2 days
The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)
Time frame: Baseline and day 7± 2 days
The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)
Time frame: 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,
Time frame: Baseline and day 7± 2 days
To assess the association between β-endorphin levels and Anhedonia
Time frame: Baseline and day 7± 2 days
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
Time frame: Baseline and day 7± 2 days
To assess the association between β-endorphin levels and Anxiety,
Time frame: Baseline and day 7± 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bénédicte NOBILE, Pharm D, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples and questionnaires in people with Suicide and Depression, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte NOBILE, Pharm D, PhD (33 (0)4 99 61 46 93, b-nobile@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline and day 7± 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.