Treatment of severe suicidal ideas in patients suffers from a current major depressive episode MedDRA version: 23.0 Level: LLT Classification code 10083288 Term: Clinical depression System Organ Class: 100000004873
Conditions
Interventions
Trade Name: BUPRENOPRPHINE MYLAN 0.4MG
Product Name: BUPRENORPHINE MYLAN 0.4MG
Pharmaceutical Form: Sublingual tablet
Pharmaceutical form of the placebo: Sublingual tablet
Route of administration of t
Sponsors
CHU DE NIMES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient is a man or a woman aged at least 18 years old and 65 years old at the most. • The patient is hospitalized or actively followed in consultation. • 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. • The patient has a current Scale for Suicidal Ideation (SSI) score > 8. • The patient must have given his/her informed and signed consent. • The patient must be insured or beneficiary of a health insurance plan. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: • The patient is participating in another interventional trial; • or is in an exclusion period determined by a previous study; • or is under judicial protection, or is an adult under guardianship; • or is under compulsory admission; • or refuses to sign the consent; • or it is impossible to correctly inform the patient. • The patient is pregnant or breastfeeding. • The patient suffers from schizophrenia; • The patient has a lifetime history of substance use disorder (except tobacco and caffeine) alcohol or benzodiazepine use disorder according to DSM-5 criteria; • The patient has received Electroconvulsivotherapy (ECT) over the last 3 months. • 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 (incl. NSAID and paracetamol); • The patient takes central nervous depressant drugs at sedative doses (based on the investigator’s assessment), including benzodiazepines, antihistamines, and sedative antipsychotics; • The patient receives major CYP3A4 Inhibitors and inducers medication; • Contra-indications mentioned for in SCP (Summary of product characteristics) of buprénorphine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show a significant effect of buprenorphine vs. placebo for the treatment of suicidal ideas at Day 7, and assess the most effective dosage (0.4mg vs. 0.8mg) of buprenorphine.;Secondary Objective: 1) Efficacy: A- To show maintenance of a significant effect of buprenorphine on suicidal ideas, on psychological pain and a mediating effect of psychological pain C- To determine the effect of buprenorphine on depressive symptoms (excluding suicidal ideas and psychological pain). D- To determine the treatment arm with the lowest number of discontinuations for inefficiency according to the patient E- To determine the number of suicide attempts or completed suicides during follow-up 2) Tolerance: A- To determine the dose of buprenorphine with the best tolerance profile from D0 to D14 and the frequency of withdrawal symptoms from D14 to D21 for each dose. 3) Mechanisms: To determine the physiological mechanisms of psychological pain and suicidal ideation, response to buprenorphine treatment in terms of: A- Neuropsychological processes. B. Brain processes. C- To create a biobank ;Primary end point(s): Scores on the Scale for Suicidal Ideation;Timepoint(s) of evaluation of this end point: DAY 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1A -Score on the SSI 1B-Psychological pain evaluation by a Visual Analog Scale (PPP-VAS) 1C-Scores at the Beck Depression Inventory (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS) after excluding the suicidal ideation items. 1D-Reports of the reasons for discontinuing treatment 1E-Reports of suicide attempts and suicide completion after the treatment phase 2A-Reports of side effects 2B-Reports of withdrawal symptoms 3A-Scores at neuropsychological tests 3B-3T Magnetic Resonance Imaging measurements 3C-Blood and stool samples collection to create a biobank ;Timepoint(s) of evaluation of this end point: 1A- D2, D14, D21, D28, D42 1B- D0, D2, D7, D14, D21, D28, D42 1C- D0, D7, D14, D21, D28, D42 1D- D2, D7, D14 1E-D90 2A-D2, D7, D14 2B-D21 3A-D0, D28 3B-D0, D28 3C-D0, D7, D14, D28 | — |
Countries
France
Contacts
Public ContactLEONIE GAZEL
CHU DE NIMES
Outcome results
None listed