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    Summary
    EudraCT Number:2018-003816-38
    Sponsor's Protocol Code Number:PHRC-N/2017-FJ-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-003816-38
    A.3Full title of the trial
    Add-on buprenorphine at analgesic doses for the treatment of severe suicidal ideas during a major depressive episode
    Traitement des idées suicidaires sévères durant un épisode dépressif caractérisé par adjonction de buprénorphine à doses antalgiques.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Add-on buprenorphine for the treatment of severe suicidal ideas
    Traitement des idées suicidaires sévères par adjonction de buprénorphine
    A.3.2Name or abbreviated title of the trial where available
    BUPRIS
    BUPRIS
    A.4.1Sponsor's protocol code numberPHRC-N/2017-FJ-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU DE NIMES
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU DE NIMES
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE NIMES
    B.5.2Functional name of contact pointLEONIE GAZEL
    B.5.3 Address:
    B.5.3.1Street AddressPLACE DU PR DEBRE
    B.5.3.2Town/ cityNIMES
    B.5.3.3Post code30029
    B.5.3.4CountryFrance
    B.5.4Telephone number33466685001
    B.5.5Fax number33466683400
    B.5.6E-maildrc@chu-nimes.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BUPRENOPRPHINE MYLAN 0.4MG
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBUPRENORPHINE MYLAN 0.4MG
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BUPRENOPRPHINE MYLAN 0.4MG
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBUPRENORPHINE MYLAN 0.8MG
    D.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSublingual tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of severe suicidal ideas in patients suffers from a current major depressive episode
    Traitement des idées suicidaires chez les patients souffrant de depression caractérisée
    E.1.1.1Medical condition in easily understood language
    Treatment of severe suicidal ideation in patients with major depression
    Traitement des idées suicidaires chez les patients avec depression caractérisée
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083288
    E.1.2Term Clinical depression
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    L’objectif principal de l’étude est de montrer un effet significatif de la buprénorphine versus placebo sur la réduction des idées suicidaires à J7 et de déterminer la dose la plus efficace (0,4 mg versus 0,8 mg).
    E.2.2Secondary objectives of the trial
    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
    Les objectifs secondaires sont :
    1) Efficacité:
    A- Montrer le maintien de l’effet significatif de la buprénorphine sur les idées suicidaires et sur la douleur psychologique.
    C- Déterminer l’effet de la buprénorphine sur les symptômes de dépression (hors idées suicidaires et douleur psychologique).
    D- Déterminer quel est le bras de traitement ayant le plus faible nombre d’arrêts de traitement expérimental pour cause d’inefficacité selon le patient
    E- Déterminer le nombre de tentatives de suicide ou suicides aboutis durant le suivi
    2) Tolérance:
    A- Déterminer la dose de buprénorphine ayant le meilleur profil de tolérance de J0 à J14.
    B- Déterminer la fréquence des symptômes de sevrage pour chaque dose.
    3) Processus impliqués:
    Pour déterminer les mécanismes physiologiques de la douleur psychologique et de l’idéation suicidaire, la réponse au traitement buprénorphine en termes de :
    A- Processus neuropsychologiques.
    B. Processus cérébraux.
    C- Constitution d’une biobanque
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    • hommes et femmes âgés de 18 à 65 ans
    • hospitalisés ou en externe
    • présentant un épisode dépressif caractérisé sans caractéristiques psychotiques selon les critères du DSM-5 et un score MADRS > 20, dans le cadre d’un trouble dépressif ou bipolaire.
    • Patient avec un niveau d’idées suicidaires > 8 sur l’échelle d’idéation suicidaire de Beck (SSI).
    • Patient ayant signé un consentement.
    • Patient affilié ou bénéficiaire d’un régime d’assurance maladie.
    E.4Principal 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.
    • le patient participe à une autre étude interventionnelle,
    • ou est en période d’exclusion déterminée par une étude précédente,
    • ou est sous sauvegarde de justice, sous tutelle ou sous curatelle,
    • ou en hospitalisation sous contrainte,
    • ou refuse de signer le consentement,
    • ou il s’avère impossible de donner au sujet des informations éclairées.
    • La patiente est enceinte ou elle allaite.
    • Le patient souffre de schizophrénie.
    • Le patient a une histoire dans sa vie de trouble de l’utilisation de substances (en dehors du tabac et de la caféine), d’alcool ou de benzodiazépines, selon les critères DSM-5.
    • Le patient a reçu un traitement par électroconvulsivothérapie (ECT) durant les 3 derniers mois.
    • Le patient souffre actuellement d'un état médical grave et/ou instable (y compris une grave insuffisance respiratoire ou hépatique) ou d'un état médical douloureux.
    • Le patient souffre actuellement d'une apnée du sommeil connue.
    • Le patient suit actuellement un traitement analgésique (AINS et paracétamol inclus).
    • Le patient reçoit un traitement du système nerveux central sédatif majeur en cours incluant benzodiazépines, antihistaminiques et antipsychotique sédatif.
    • Le patient reçoit un traitement inhibiteur ou inducteur du CYP3A4.
    • Contre-indication mentionnée dans le RCP de la Buprénophine.
    E.5 End points
    E.5.1Primary end point(s)
    Scores on the Scale for Suicidal Ideation
    Score du Scale for Suicidal Ideation
    E.5.1.1Timepoint(s) of evaluation of this end point
    DAY 7
    JOUR 7
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    DATE DE GEL DE BASE
    DATE DE GEL DE BASE
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months33
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months33
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    aucun
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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