Informations générales (source: ClinicalTrials.gov)
Add-on Buprenorphine At Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode (BUPRIS)
Interventional
Phase 3
Centre Hospitalier Universitaire de Nīmes (Voir sur ClinicalTrials)
octobre 2021
janvier 2026
19 octobre 2024
This study aims at investigating if adjunctive buprenorphine at low dose to treatment as
usual is effective in reducing severe suicidal ideas in major depressive episode, and at
determining the most effective dose.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Tours - 37540 - Tours - France | Wissam El-Hage, MD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - 69003 - Lyon - France | Emmanuel Poulet, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CAPPA Jacques PREVERT - 44000 - Nantes - France | Anne Sauvaget, MD | Contact (sur clinicalTrials) | |||
| CH Henri Laborit - 86021 - Poitiers - France | Nemat Jaafari, MD | Contact (sur clinicalTrials) | |||
| Ch Perrens - 33076 - Bordeaux - France | TOURNIER MARIE, PUPH | Contact (sur clinicalTrials) | |||
| CH Sainte-Anne - 75674 - Paris - France | Fabrice Jollant, MD | Contact (sur clinicalTrials) | |||
| CHU Bicêtre - 94270 - Le Kremlin-Bicêtre - France | Emmanuelle Corruble, MD | Contact (sur clinicalTrials) | |||
| CHU Nîmes - 30029 - Nîmes - France | Mocrane Abbar, MD | Contact (sur clinicalTrials) | |||
| Chu Toulouse Hopital Purpan - 31059 - Toulouse - France | YRONDI ANTOINE, M.D.,Ph.D. | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- The patient has been correctly informed.
- The patient must have given his/her informed and signed the consent form.
- The patient must be insured or beneficiary of a health insurance plan.
- The patient is at least 18 years old and 65 years old at the most.
- The patient is hospitalized or followed in consultation.
- The patient has a current major depressive episode without psychotic features
according to the criteria of the "Diagnostic and Statistical Manual of Mental
Disorders"
- The patient has a score > 20 of the "Montgomery-Asberg Depression Rating Scale".
- The patient has a current Scale for Suicidal Ideation (SSI) score > 8.
- The patient has been correctly informed.
- The patient must have given his/her informed and signed the consent form.
- The patient must be insured or beneficiary of a health insurance plan.
- The patient is at least 18 years old and 65 years old at the most.
- The patient is hospitalized or followed in consultation.
- The patient has a current major depressive episode without psychotic features
according to the criteria of the "Diagnostic and Statistical Manual of Mental
Disorders"
- The patient has a score > 20 of the "Montgomery-Asberg Depression Rating Scale".
- The patient has a current Scale for Suicidal Ideation (SSI) score > 8.
- The patient is participating in another interventional trial;
- The patient is in an exclusion period determined by a previous study;
- The patient is under judicial protection, or is an adult under guardianship;
- The patient is under compulsory admission;
- The patient refuses to sign the consent;
- it is impossible to correctly inform the patient.
- The patient is pregnant or breastfeeding.
- The patient suffers from schizophrenia;
- The patient suffered from moderate to severe alcohol use disorder or substance use
disorder (except tobacco and caffeine) over the last 12 months according to DSM-5
criteria ;
- The patient currently suffers from severe and/or unstable medical condition
(including severe respiratory or hepatic insufficiency) or a painful medical
condition;
- The patient has a current known sleep apnea.
- The patient currently takes analgesic treatment (including Nonsteroidal
anti-inflammatory drug and paracetamol);
- The patient currently takes central nervous depressant drugs at sedative doses
(based on the investigator's assessment), including benzodiazepines, antihistamines,
and sedative antipsychotics;
- The patient currently takes major CYP3A4 Inhibitors and inducers;
- The patient currently takes has received Electroconvulsivotherapy over the last 3
months.