BUPRENORPHINE for Major depressive episode | Clinical depression | Suicidal ideation

Inclusion criteria

• {"criterion_text":"- The patient is a man or a woman aged at least 18 years old and 65 years old at the most.\n- The patient is hospitalized\n- The patient suffers from a current major depressive episode without psychotic features according to DSM-5 criteria and a Montgomery-Asberg Depression Rating Scale (MADRS) score > 20, as part of a bipolar or major depressive disorder.\n- The patient has a current Scale for Suicidal Ideation (SSI) score > 8.\n- The patient must have given his/her informed and signed consent.\n- The patient must be insured or beneficiary of a health insurance plan."}

Exclusion criteria

• {"criterion_text":"- The patient is participating in another interventional trial;\n- 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\n- The patient has received Electroconvulsivotherapy (ECT) over the last 3 months.\n- The patient currently suffers from severe and/or unstable medical condition (including severe respiratory, renal or hepatic insufficiency) or a painful medical condition;\n- The patient has a current known sleep apnea.\n- The patient has a severe renal impairment\n- The patient currently takes analgesic treatment (incl. NSAID and paracetamol);\n- The patient takes central nervous depressant drugs at sedative doses (based on the investigator’s assessment), including sedative antidepressants, benzodiazepines, antihistamines, and sedative antipsychotics;\n- The patient receives major CYP3A4 Inhibitors and inducers medication;\n- Contra-indications mentioned for in SCP (Summary of product characteristics) of buprénorphine.\n- Use of alcohol or medication containing alcohol\n- The patient is in an exclusion period determined by a previous study;\n- Patient receives a Monoamine Oxydase Inhibitor (MAOI) antidepressant\n- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Hypersensitivity to the active substance or to any of the excipients mentioned in section 6.1. of the SCP\n- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Severe respiratory insufficiency (Altered respiratory function due to any medical condition (e.g chronic obstructive pulmonary disease, asthma, hypoxia, hypercapnia, pre-exisiting respiratory depression)\n- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Severe hepatic insufficiency\n- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Acute alcohol poisoning or delirium tremens.\n- Contra-indications mentioned in SCP (Summary of product characteristics) of buprénorphine and in particular Combination with méthadone, level III morphinic painkillers, naltrexone, and nalméfène.\n- The patient is under judicial protection, or is an adult under guardianship;\n- The patient is under compulsory admission;\n- The patient refuses to sign the consent\n- it is impossible to correctly inform the patient.\n- The patient actively followed in consultation\n- The patient is pregnant or breastfeeding.\n- The patient suffers from schizophrenia"}

Primary endpoints

• {"endpoint_text":"- Scores on the Scale for Suicidal Ideation (SSI) at Day 7 for the last 7 days","definition_or_measurement_approach":"Scale for Suicidal Ideation (SSI) score at Day 7, assessment referring to the last 7 days."}

Secondary endpoints

• {"endpoint_text":"- Score on the SSI from D7 to 42 for the last 7 days (except at D2 = for the last 2 days)","definition_or_measurement_approach":"SSI score assessed from Day 7 to Day 42 for the last 7 days (Day 2 assessment covers last 2 days)."}
• {"endpoint_text":"- Psychological pain evaluation by a Visual Analog Scale (PPP-VAS) from D0 to D42 (current and for the last 7 days, except at D2 = for the last 2 days)","definition_or_measurement_approach":"Psychological pain measured using a Visual Analog Scale (PPP-VAS) from Day 0 to Day 42; assessments specify current and last 7 days (Day 2 for last 2 days)."}
• {"endpoint_text":"- Scores at the Beck Depression Inventory (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS) after excluding the suicidal ideation items, for the last 7 days.","definition_or_measurement_approach":"BDI-II and MADRS scores excluding items related to suicidal ideation, assessed for the last 7 days."}
• {"endpoint_text":"- Reports of the reasons for discontinuing treatment","definition_or_measurement_approach":"Collection and reporting of reasons for treatment discontinuation as recorded during the study."}
• {"endpoint_text":"- Reports of suicide attempts and suicide completion after the treatment phase","definition_or_measurement_approach":"Recording of occurrences of suicide attempts and completed suicides during follow-up after treatment phase."}
• {"endpoint_text":"- Reports of side effects","definition_or_measurement_approach":"Adverse events and side effects reported and recorded during the study period."}
• {"endpoint_text":"- Reports of withdrawal symptoms","definition_or_measurement_approach":"Recording and reporting of withdrawal symptoms (noted timing D14 to D21 for frequency by dose in objectives)."}
• {"endpoint_text":"- Scores at neuropsychological tests","definition_or_measurement_approach":"Neuropsychological test scores recorded as per protocol assessments."}
• {"endpoint_text":"- 3T Magnetic Resonance Imaging measurements","definition_or_measurement_approach":"3 Tesla MRI measurements (structural and functional) according to imaging protocol."}
• {"endpoint_text":"- Blood and stool samples collection to create a biobank","definition_or_measurement_approach":"Collection of blood and stool samples to constitute a biobank for ancillary/biochemical analyses."}

France

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

17-10-2024

Processing Time Days

213

Number Of Sites

1

Number Of Participants

180

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nimes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France