Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004586-24
    Sponsor's Protocol Code Number:ESKETINTRD3003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-10
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-004586-24
    A.3Full title of the trial
    A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression
    Uno studio randomizzato, in doppio cieco, multicentrico, controllato attivamente con Esketamine intra nasale abbinata ad un antidepressivo orale per la prevenzione delle recidive nella depressione resistente al trattamento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse
    Prevention in Adult Participants With Treatment-resistant Depression
    Uno studio con Esketamine intra nasale abbinata ad un antidepressivo orale per la prevenzione delle recidive nella depressione resistente al trattamento.
    A.3.2Name or abbreviated title of the trial where available
    SUSTAIN-1
    SUSTAIN-1
    A.4.1Sponsor's protocol code numberESKETINTRD3003
    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 SponsorJANSSEN CILAG INTERNATIONAL NV
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJANSSEN CILAG SPA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportJANSSEN CILAG INTERNATIONAL NC
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG INTERNATIONAL NV
    B.5.2Functional name of contact pointCLINICAL REGISTRY GROUP
    B.5.3 Address:
    B.5.3.1Street AddressARCHIMEDESWEG 29
    B.5.3.2Town/ cityLEIDEN
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 No
    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.3.4Pharmaceutical form Nasal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESKETAMINE Esketamine (for (S)-2-(o-chlorophenyl)-2- (methylamino)cyclohexanone)
    D.3.9.2Current sponsor codeEsketamine
    D.3.9.3Other descriptive nameEsketamine
    D.3.9.4EV Substance CodeSUB25811
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number161.4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleComparator
    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 CYMBALTA - 30 MG CAPSULE RIGIDE GASTRORESISTENTI USO ORALE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCYMBALTA
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDULOXETINA CLORIDRATO
    D.3.9.1CAS number 136434-34-9
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameDULOXETINA CLORIDRATO
    D.3.9.4EV Substance CodeSUB20026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 CIPRALEX - 10mg film coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderH. LUNDBECK A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameCIPRALEX
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESCITALOPRAM
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB16425MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 ZOLOFT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsertraline hydrochloride
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameSERTRALINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB04375MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Trevilor retard, capsule a rilascio prolungato da 75mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Prolonged-release capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVENLAFAXINE HYDROCHLORIDE
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB05087MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment-resistant Major Depression
    Depressione maggiore resistente al trattamento.
    E.1.1.1Medical condition in easily understood language
    Depression is a mental disorder characterized by low mood and/or loss of interest or pleasure in nearly all activities.
    La depressione è un disordine mentale caratterizzato da umore negativo e/o perdita di interesse o piacere in quasi tutte le attività
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in subjects with TRD who are in stable
    remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.
    L’obiettivo primario di questo studio è valutare l’efficacia di Esketamine intra nasale associata ad un antidepressivo orale rispetto ad un antidepressivo orale (comparatore attivo) in combinazione con il placebo intra nasale nel ritardare la recidiva dei sintomi di depressione in soggetti con TRD in remissione stabile dopo un ciclo di induzione ed ottimizzazione con Esketamine intra nasale in combinazione con un antidepressivo orale.
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in subjects with TRD with stable response (but who are not in stable remission) after an induction and optimization courseof intranasal
    esketamine plus an oral antidepressant.
    -To assess the effect of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo on various parameters (see protocol
    for details).
    - To investigate the safety and tolerability of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active
    comparator) plus intranasal placebo in subjects with TRD (see protocol for details)
    -Valutare l’efficacia di Esketamine intra nasale abbinata ad un antidepressivo orale rispetto ad un antidepressivo orale (comparatore attivo) abbinato al placebo intra nasale nel ritardare la recidiva di sintomi depressivi in soggetti con TRD con risposta stabile (ma non in remissione stabile) dopo un ciclo di induzione e ottimizzazione con Esketamine intra nasale abbinata a un antidepressivo orale.
    -Valutare l’effetto di Esketamine intra nasale abbinata ad un antidepressivo orale rispetto ad un antidepressivo orale (comparatore attivo) associato al placebo intra nasale rispetto a vari parametri (vedere il protocollo).
    -Studiare la sicurezza e la tollerabilità di Esketamine intra nasale associata ad un antidepressivo orale rispetto ad un antidepressivo orale (comparatore attivo) abbinato al placebo intra nasale in soggetti con TRD (vedere il protocollo per i dettagli).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For Direct-Entry Participants:
    - At the time of signing the informed consent form (ICF), participant must be a man or woman 18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18) to 64 years of age, inclusive
    - At the start of the screening/prospective observational phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single episode MDD, the duration must be greater than or equal to [>=] 2 years) or recurrent MDD, without
    psychotic features, based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
    - At the start of the screening/prospective observational phase, participant must have an Inventory of Depressive Symptomatology- Clinician rated ( IDS-C30) total score of greater than or equal to (>=) 34
    - At the start of the screening/prospective observational phase, participants must have had nonresponse to >=2 but less than or equal to (<=) 5 oral antidepressant treatments taken at adequate dosage and for adequate duration, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGHATRQ) and documented by medical history and pharmacy/prescription records, for the current episode of depression
    - The participant's current major depressive episode and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be deemed valid for
    participation in a clinical study based on a Site-Independent Qualification Assessment For Transferred-Entry Participants
    Per partecipanti ad accesso diretto:
    -Al momento della firma del modulo di consenso informato (ICF), il soggetto, uomo o donna, deve avere un’età compresa tra 18 anni (o più se l’età legale minima richiesta per il consenso nel paese in cui viene condotto lo studio è maggiore di 18 anni) e 64 anni (estremi inclusi).
    -All’inizio della fase di screening/osservazione prospettica, ogni soggetto deve soddisfare i criteri diagnostici del Manuale Diagnostico e Statistico sui Disturbi Mentali - quinta edizione (DSM-5) per l’MDD a episodio singolo (in caso di MDD a episodio singolo, la durata deve essere >= 2 anni) o l’MDD ricorrente, senza caratteristiche psicotiche, sulla base della valutazione clinica e con conferma tramite l’intervista MINI (Mini International Neuropsychiatric Interview).
    -All’inizio della fase di screening/osservazione prospettica, ogni soggetto deve avere un punteggio totale IDS-C30 (Inventory of Depressive Symptomatology, Clinician-rated, 30-item) ≥34.
    -All’inizio della fase di screening/osservazione prospettica, ogni soggetto deve aver presentato una mancata risposta a >= 2 ma <= 5 ai regimi terapeutici con antidepressivi orali nel corso dell’episodio corrente di depressione, valutata con il questionario MGH-ATRQ (Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire) e confermata da anamnesi/prescrizioni documentate.
    -L’episodio depressivo maggiore corrente del soggetto e la sua risposta al trattamento antidepressivo nel corso dell’episodio corrente (valutato retrospettivamente) devono essere considerati validi per la partecipazione allo studio clinico in base alla valutazione di qualifica indipendente dal centro.
    E.4Principal exclusion criteria
    - Participants who have previously demonstrated nonresponse of depressive symptoms to esketamine or ketamine in the current major depressive episode, to all 4 of the oral antidepressant treatment options available for the double-blind induction phase (ie, duloxetine, escitalopram, sertraline, and venlafaxine extended release [XR]) in the current major depressive episode (based on MGH-ATRQ), or an adequate
    course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral ECT
    - Participant currently has an implant for vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression
    - Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders (confirmed by the MINI), comorbid obsessive compulsive disorder, intellectual disability (only DSM-5 diagnostic code 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder,
    or narcissistic personality disorder
    - Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening/prospective observational phase, per the investigator's clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS)
    - Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria
    -Partecipanti che hanno precedentemente dimostrato di non rispondere a Esketamine o Ketamina nell’episodio depressivo maggiore corrente, a tutti i 4 antidepressivi orali disponibili per la fase di induzione in aperto (ossia duloxetina, escitalopram, sertralina e venlafaxina XR) nell’episodio depressivo maggiore corrente (sulla base del MGH-ATRQ) o ad un ciclo di trattamento adeguato con terapia elettroconvulsiva (ECT) nell’episodio depressivo maggiore corrente, definito come almeno 7 trattamenti con ECT unilaterale.
    -Il soggetto è attualmente portatore di un impianto per la stimolazione del nervo vago (VNS) o ha ricevuto una stimolazione cerebrale profonda (DBS) nell’episodio corrente di depressione.
    -Il soggetto ha una diagnosi DSM-5 corrente o precedente di disturbo psicotico o MDD con psicosi, disturbi bipolari o correlati (confermati tramite MINI), disturbo compulsivo ossessivo in comorbidità, disabilità intellettuale (solo codice diagnostico DSM-5 319), disturbo di personalità borderline, disturbo di personalità antisociale, disturbo di personalità istrionica o disturbo di personalità narcisista.
    -Il soggetto ha idee/intenzioni di natura omicida, secondo il giudizio medico dello sperimentatore, oppure ha idee suicide con intenzione di agire nei 6 mesi precedenti l’inizio della fase di screening/osservazione prospettica, secondo il giudizio medico dello sperimentatore o sulla base della scala C-SSRS, che corrisponde alla risposta “Sì” alla voce 4 (idee suicide attive con intenzione di agire, senza un piano specifico) o 5 (idee suicide attive con piano ed intenzione specifici) sull’ideazione suicidaria della scala C-SSRS
    -Il soggetto ha una storia di disturbo legato all’abuso moderato o grave di sostanze o alcol in base ai criteri DSM-5
    E.5 End points
    E.5.1Primary end point(s)
    time to relapse in partecipants with stable remission who were randomized in the maintenance phase
    tempo fino alla ricaduta nei pazienti con remissione stabile randomizzati nella fase di mantenimento
    E.5.1.1Timepoint(s) of evaluation of this end point
    time between partecipant randomization into the maintenance phase and the first documentation of relapsed event.
    tempo fra la randomizzazione nella fase di mantenimento e la documentazione di ricaduta
    E.5.2Secondary end point(s)
    1) Time to relapse in Participants with Stable Response (but not in
    stable remission) who were randomized in the maintenance phase.
    2) Change From Baseline in MADRS total score at end of the Maintenance
    Phase in participants who were randomized in this phase.
    3) Change From Baseline in Subject-reported Depressive Symptoms
    Using the Patient Health Questionnaire-9 (PHQ-9) Total Score at End of
    the Maintenance Phase in participants who were randomized in this
    phase.
    4) Change From Baseline in Clinical Global Impression – Severity (CGI-S)
    Score at End of Maintenance Phase in participants who were randomized
    in this phase.
    5) Change From Baseline in Subject-reported Generalized Anxiety
    Disorder (GAD-7) Score at End of Maintenance Phase in participants who
    were randomized in this phase.
    6) Change From Baseline in Subject-reported Health-related Quality of
    Life and Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-
    5D-5L) at End of Maintenance Phase in participants who were
    randomized in this phase.
    7) Change From Baseline in Sheehan Disability Scale (SDS) Total Score
    at End of Maintenance Phase in participants who were randomized in
    this phase.
    8) Number of Participants with Adverse Events (AEs) and Serious AEs.
    1) Tempo alla recidiva in partecipanti con risposta stabile (ma non in remissione stabile) randomizzati nella fase di mantenimento.
    2) Variazione dal basale nel punteggio MADRS totale alla fine della fase di mantenimento
    3) Variazione dal basale del punteggio totale della valutazione del paziente nel questionario Patient Health Questionnaire-9 (PHQ-9) alla fine della fase di mantenimento in partecipanti randomizzati in questa fase.
    4) Variazione dal basale del punteggio Clinical Global Impression – Severity (CGI-S)alla fine della fase di mantenimento dei pazienti randomizzati in questa fase.






    5) Variazione dal basale del punteggio totale della valutazione del paziente nel Generalized Anxiety Disorder (GAD-7) alla fine della fase di mantenimento in partecipanti randomizzati in questa fase.


    6) Variazione dal basale del punteggio totale della valutazione del paziente nel Health-related Quality of Life and Health Status as Assessed - EuroQol-5 Dimension-5 Level (EQ- 5D-5L) alla fine della fase di mantenimento in partecipanti randomizzati in questa fase.
    7) Variazione dal basale del punteggio totale nella scala Sheehan Disability Scale (SDS) fino alla fine della fase di mantenimento in partecipanti randomizzati in questa fase.
    8) Numero di partecipanti con Eventi Avversi (AEs) e Eventi Avversi Seri.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Time between participant randomization into the maintenance phase
    and the first documentation of a relapse event.
    2) Baseline and End of Maintenanace Phase.
    3) Baseline and End of Maintenance Phase.
    4) Baseline and End of Maintenance Phase.
    5) Baseline and End of Maintenance Phase.
    6) Baseline and End of Maintenance Phase.
    7) Baseline and End of Maintenance Phase.
    8) Screening up to End of Follow-up Phase (up to 2 weeks after last dose
    of study drug).
    1) Tempo fra la randomizzazione nella fase di mantenimento e la prima documentazione di ricaduta.
    2) Baseline e fine della fase di mantenimento.
    3) Baseline e fine della fase di mantenimento.
    4) Baseline e fine della fase di mantenimento.
    5) Baseline e fine della fase di mantenimento.
    6) Baseline e fine della fase di mantenimento.
    7) Baseline and End of Maintenance Phase.
    8) Screening fino alla fine della fase di follow-up (fino a 2 settimane dopo l'ultima dose di farmaco in studio).
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Mexico
    Poland
    Spain
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    ULTIMA VISITA ULTIMO SOGGETTO
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 498
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 208
    F.4.2.2In the whole clinical trial 498
    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)
    Subjects will be return to standard of care treatment following participation in the study.
    Dopo la fine dello studio i pazienti torneranno al trattamento standard
    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 Decision2015-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-16
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA