Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 7:07 AM
Study NCT ID:
NCT06291467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma Beta-endorphin Levels and Suicidal Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'Baseline and day 7± 2 days', 'description': 'blood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)'}], 'secondaryOutcomes': [{'measure': '- 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.', 'timeFrame': 'Baseline and day 7± 2 days', 'description': 'blood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)'}, {'measure': 'The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)', 'timeFrame': 'Baseline and day 7± 2 days', 'description': '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) .'}, {'measure': 'The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)', 'timeFrame': 'Baseline and day 7± 2 days', 'description': '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).'}, {'measure': 'To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion,', 'timeFrame': 'Baseline and day 7± 2 days', 'description': '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)'}, {'measure': 'To assess the association between β-endorphin levels and Anhedonia', 'timeFrame': 'Baseline and day 7± 2 days', 'description': '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)'}, {'measure': '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', 'timeFrame': 'Baseline and day 7± 2 days', 'description': '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.'}, {'measure': 'To assess the association between β-endorphin levels and Anxiety,', 'timeFrame': 'Baseline and day 7± 2 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['suicide', 'depression', 'beta endorphin'], 'conditions': ['Suicide', 'Depression', 'Beta Endorphin']}, 'descriptionModule': {'briefSummary': 'It is an interventional research, monocentric, which involves only minimal risks and constraints.\n\nPsychological 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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '104 participants will be enrolled, divided into 2 groups:\n\ngroup 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;\n\nThe 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).\n\nThe 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 .\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Common inclusion criteria:\n* Aged between 18 and 65 years old,\n* Subject with a psychiatric diagnosis of current major depressive episode according to DSM-5 criteria\n* Able to understand the nature, purpose and methodology of the study\n\nSpecific inclusion criteria\n\n* Suicide attempters: Subject hospitalized for of proven suicide attempt (\\<72h)\n* 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)\n\nNon inclusion criteria\n\n* Diagnosis of bipolar disorder\n* Lifetime diagnosis of schizoaffective disorder, schizophrenia or unspecified psychosis\n* Current diagnostic of illicit substance / alcohol use disorder within the last 6 months\n* Diabetes or obesity (BMI \\> 29)\n* Inflammatory disease (e.g. Lupus, Rheumatoid Arthritis)\n* Receiving opiate treatment or opiate substitution treatment\n* Law protected ( guardianship or curatorship)\n* Deprived of liberty (by judicial or administrative decision or forced hospitalization)\n* Pregnant and breastfeeding women\n* Inability to understand, speak and write French\n* Refusal to participate in the study.\n* Not be affiliated to a French National Social Security System'}, 'identificationModule': {'nctId': 'NCT06291467', 'acronym': 'BEST', 'briefTitle': 'Plasma Beta-endorphin Levels and Suicidal Behavior', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Plasma Beta-endorphin Levels and Suicidal Behavior', 'orgStudyIdInfo': {'id': 'RECHMPL23_0121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suicide attempters', 'description': 'patients hospitalized for suicide attempt within the last 72 hours', 'interventionNames': ['Biological: Blood samples', 'Other: questionnaires']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Affective controls', 'description': 'patients hospitalized for current major depressive episode according to DSM-5 criteria and without any lifetime history of suicide attempt', 'interventionNames': ['Biological: Blood samples', 'Other: questionnaires']}], 'interventions': [{'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': 'Blood samples will be collected at both visit between 8:30 a.m. and 9:30 a.m. and fasting from midnight.', 'armGroupLabels': ['Affective controls', 'Suicide attempters']}, {'name': 'questionnaires', 'type': 'OTHER', 'description': "Questionnaires will be administrated at both visits to assess the suicide spectrum, the depression level and some personality traits.\n\nHetero-questionnaires will be administrated during a clinical interview conducted by a psychiatrist or psychologist at the inclusion.\n\n* MINI 7.0 Mini-International Neuropsychiatric Interview :\n* MADRS (Montgomery Asberg Depression Scale)\n* C-SSRS (Columbia-Suicide Severity Rating Scale)\n* FAST (Functioning Assessment Short Test)\n\nSelf-administered questionnaire will be completed by the participant at the inclusion and at the end of hospitalisation (D7+/- 2 days) :\n\n* STAI-Y (State-Trait Anxiety Inventory )\n* PPP-VAS (Visual Analog Scale to measure Psychological and Physical Pain)\n* SHAPS (Snaith-Hamilton-Pleasure Scale )\n* CTQ (Childhood Trauma Questionnaire)\n* ESUL : Echelle de solitude de l'université de Laval\n* BIS-11 : (Barratt Impulsiveness Scale)\n* QIDS (Quick Inventory of Depressive Symptomatology)", 'armGroupLabels': ['Affective controls', 'Suicide attempters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Jessica DALAUDIERE', 'role': 'CONTACT', 'email': 'jessica.dalaudiere@chu-montpellier.fr'}], 'facility': 'University hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Bénédicte NOBILE, Pharm D, PhD', 'role': 'CONTACT', 'email': 'b-nobile@chu-montpellier.fr', 'phone': '33 (0)4 99 61 46 93'}, {'name': 'Philippe COURTET, MD PhD', 'role': 'CONTACT', 'email': 'p-courtet@chu-montpellier.fr', 'phone': '+33467338581'}], 'overallOfficials': [{'name': 'Bénédicte NOBILE, Pharm D, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de Génomique Fonctionnelle (IGF) de Montpellier', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}