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A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esketamine 28 mg
Esketamine 56 mg
Esketamine 84 mg
Quetiapine XR 50 mg
Quetiapine XR 100 mg
Quetiapine XR 150 mg
SSRI/SNRI
Sponsored by
Janssen-Cilag International NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At screening, each participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI)
  • At screening and baseline, each participant must have an Inventory of Depressive Symptomatology - Clinician-rated, 30 item (IDS-C30) total score of greater than or equal to (>=) 34
  • Must be on a current antidepressive treatment that includes an selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake inhibitor (SNRI) at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (based on antidepressive dosages from SmPC [or local equivalent, if applicable]) for an adequate duration of at least 6 weeks and having been uptitrated to the maximum tolerated dose; however, at screening the participant must show signs of minimal clinical improvement to be eligible for the study. Clinical improvement of a participant on their current AD treatment will be retrospectively evaluated in a qualified psychiatric interview performed by an experienced clinician. At baseline (Day 1) prior to randomization, the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current AD treatment are still met (that is nonresponse and minimal clinical improvement)
  • The current antidepressive treatment, was immediately preceded by nonresponse to at least 1 but not more than 5 different, consecutive treatments (all within the current moderate to severe antidepressive episode) with anti-depressants (ADs) taken at an adequate dosage for an adequate duration of at least 6 weeks and must be documented
  • Must have been treated with at least 2 different antidepressive substance classes among the treatments taken at an adequate dosage for an adequate duration of at least 6 weeks resulting in nonresponse in the current moderate to severe depressive episode (including the current treatment with an selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor [SSRI/SNRI])
  • Must be on a single oral SSRI/SNRI on Day 1 prior to randomization

Exclusion Criteria:

  • Received treatment with esketamine or ketamine in the current moderate to severe depressive episode
  • Received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 milligram per day (mg/day)
  • Had depressive symptoms in the current moderate to severe depressive episode that previously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT
  • Has no signs of clinical improvement at all or with a significant improvement on their current AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview
  • Received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
  • has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the Mini International Neuropsychiatric Interview [MINI]), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, or antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
  • age at onset of first episode of MDD was more than or equal to (>=) 55 years
  • has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to screening, per the investigator's clinical judgment; or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded

Sites / Locations

  • FunDaMos
  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
  • CEN-Consultorios Especializados en Neurociencias
  • Fundacion Lennox
  • Instituto Médico DAMIC
  • Sanatorio Prof. Leon S. Morra S.A
  • Instituto de Neurociencias San Agustín
  • C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
  • Medical University Graz
  • Schmitz and Schmitz
  • Medical University Vienna, MUV
  • Anima
  • Pz Duffel
  • Clinique Psychiatrique des Frères Alexiens
  • Sint-Franciskusziekenhuis
  • ARIADNE
  • CHU de Liège
  • CPN - Centro de Pesquisa em Neurociências Ltda
  • Trial Tech Tecnologia em Pesquisas com Medicamentos
  • Ruschel Medicina e Pesquisa Clínica Ltda
  • C.J.S. Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)
  • BR Trials
  • State Psychiatric Hospital Kardzhali
  • UMHAT 'Dr. Georgi Stranski', EAD
  • Mental Health Center - Plovdiv
  • Mental Health Center - Rousse
  • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
  • MHC - Sofia, EOOD
  • Centre for Mental Health Prof.N.Shipkovenski EOOD
  • University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
  • Psychiatricka ambulance Saint Anne s.r.o.
  • Psychiatricka ambulance, MUDr. Marta Holanova
  • NeuropsychiatrieHK, s.r.o.
  • A-Shine s.r.o.
  • Institut Neuropsychiatricke pece
  • Clintrial s.r.o.
  • AD71 s.r.o.
  • Medical Services Prague s.r.o.
  • Aalborg University Hospital
  • Psykiatrien i Region Syddanmark
  • Mederon LTD at ARTES
  • Psykiatrinen Palvelukeskus Solvum Oy
  • Savon Psykiatripalvelu
  • Universitaetsklinikum der RWTH Aachen
  • Rheinhessen Fachklinik Alzey
  • Emovis GmbH
  • Charite Campus Benjamin Franklin
  • Medizinisches Versorgungszentrum LiO GmbH
  • Alexander Schulze - Germany
  • Praxis Dr. med. Kirsten Hahn
  • Vivantes Klinikum Spandau
  • Universitatsklinikum Bonn
  • Klinikum Chemnitz gGmbH
  • Carl-Thiem-Klinikum Cottbus gGmbH
  • Klinikum Dortmund gGmbH
  • Universitatsklinikum Carl Gustav Carcus Dresden
  • Universitatsklinikum Frankfurt
  • Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik
  • SRH Waldklinikum Gera GmbH
  • Georg-August Universität, Universitätsmedizin Göttingen
  • Evangelisches Krankenhaus Bethanien gGmbH
  • Universitaetsklinik Hamburg-Eppendorf
  • Klinische Forschung Hamburg
  • Klinische Forschung Hannover-Mitte GmbH
  • Medizinische Hochschule Hannover
  • Universität Heidelberg
  • Oberhavel Kliniken GmbH
  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Jena
  • Panakeia - Arzneimittelforschung GmbH
  • Universitaetsklinikum Magdeburg A.oe.R
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Pharmakologisches Studienzentrum Chemnitz GmbH
  • Universitätsklinikum Münster
  • Ruppiner Kliniken
  • Praxis Prof. Steinwachs
  • Johanniter Krankenhaus Oberhausen
  • Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik
  • Somni Bene GmbH
  • Klinische Forschung Schwerin GmbH
  • Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany
  • Aiginition Hospital of Athens
  • 'Dafni' Psychiatric Hospital of Attica
  • Venizeleio General Hospital
  • Psychiatric Clinic 'Agios Charalampos'
  • University General Hospital of Ioannina
  • University General Hospital of Rio Patras
  • 424 Military Hospital of Thessaloniki
  • Psychiatric Hospital of Thessaloniki
  • 'G. Papanikolaou' Hospital of Thessaloniki
  • Semmelweis Egyetem
  • Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú
  • Processus Kft.
  • Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
  • Bugat Pal Korhaz
  • Petz Aladar Megyei Oktato Korhaz
  • Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Rambam Medical Center
  • Shalvata Mental Health Center
  • Beer Yaakov Mental Health Center
  • Geha Mental Health Center
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Republican Scientific and Practical Center of Mental Health
  • Medical Center for Psychological Healt SME
  • East-Kazakhstan Regional Centre of Mental Health
  • Chonnam National University Hospital
  • Wonkwang University Hospital
  • KyungHee University Hospital
  • Korea University Anam Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Hospital Raja Permaisuri Bainun
  • Hospital Kuala Lumpur
  • University Malaya Medical Centre
  • Hospital Pengajar Universiti Putra Malaysia
  • Hospital Tuanku Jaafar
  • Brain Research Center
  • AMC
  • LUMC
  • Haukeland University Hospital
  • Sykehuset Ostfold
  • St Olav University Hospital
  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
  • Osrodek Badan Klinicznych CLINSANTE S.C.
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Badań Klinicznych PI-House sp. z o.o.
  • Centrum Medyczne Care Clinic Katowice
  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
  • Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego
  • SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych
  • Centrum Medyczne Luxmed Sp z o o
  • Osrodek Badan Klinicznych CLINSANTE S.C.
  • Hospital de Braga
  • Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
  • Fundação Champalimaud
  • Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
  • Hospital CUF Tejo
  • Hospital Beatriz Angelo
  • Cape Town Clinical Research Centre
  • Flexivest 14 Research
  • Gert Bosch - Pretoria South Africa
  • Psykiatriska kliniken
  • Affecta Pskyiatrimottagning
  • Psykiatriska kliniken
  • ProbarE i Lund AB
  • ONE LIFETIME Läkarmottagning
  • ProbarE i Stockholm AB
  • Changhua Christian Hospital
  • Hualien Tzu Chi Hospital
  • Kai-Syuan Psychiatric Hospital
  • Chang Gung Memorial Hospital
  • National Cheng Kung University Hospital
  • Taipei Medical University
  • National Taiwan University Hospital
  • Mackay Memorial Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Memorial Hospital
  • Hacettepe University Medical Faculty
  • Bursa Yuksek Ihtisas Training and Research Hospital
  • Uludag University Medical Faculty
  • Bakirkoy Mental Health Training and Research Hospital
  • Erenkoy Mental Health Hospital
  • Uskudar University Neuropsychiatry Hospital
  • Ege Universitesi Tip Fakultesi
  • Selcuk University Medical Faculty
  • Liv Hospital
  • Namik Kemal University
  • American Center for Psychiatry and Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Esketamine Arm

Comparator Arm

Arm Description

Participants will receive treatment with esketamine nasal spray (28 milligram [mg] [initial dose for elderly participants 65 to 74 years of age and adults of Japanese ancestry; may be used throughout the study in these populations; may be uptitrated in 28 mg increments], 56 mg [initial dose for adult participants aged 18 to 64 years and may be used for all age groups throughout the study], or 84 mg [maximum dose esketamine nasal spray may be uptitrated to]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI).

Participants will continue to take their current SSRI/SNRI augmented with quetiapine extended release (XR) as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable). In adult participants aged 18 to 64 years, the initial dose is 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 [lowest effective dose]; a further dose increase to 300 mg/day on Day 5 and onward will be based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose is 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day will be based on individual participant evaluation no earlier than Day 22.

Outcomes

Primary Outcome Measures

Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8
Percentage of participants with remission as assessed by the MADRS at Week 8 was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. A participant was defined as being in remission if the MADRS total score was less than or equal to (<=)10 and no treatment or study discontinuation before Week 8.

Secondary Outcome Measures

Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32
Percentage of participants with both remission at Week 8 and relapse-free until Week 32 were reported. A participant was defined as being in remission if the MADRS total score was <= 10 and no treatment or study discontinuation before Week 8. A relapse was defined by any of following: a) Worsening of depressive symptoms as indicated by MADRS total score greater than or equal to (>=) 22 confirmed by 1 additional assessment of MADRS total score >= 22 within the next 5 to 15 days. The date of the second MADRS assessment was used for the date of relapse; b) Any psychiatric hospitalization for: worsening of depression, suicide prevention or suicide attempt, the start date of hospitalization was the date of relapse; c) Suicide attempt, completed suicide, or any other clinically relevant event determined by investigator's judgment to be indicative of a relapse of depressive illness, but without hospitalized. The onset of the event was used for the date of relapse.
Change From Baseline in Clinician-rated Overall MADRS Score
Change from baseline in clinician-rated overall MADRS score was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts.
Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)
Change from baseline in clinician-rated overall MADRS score at LOCF was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score
Change from baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement.
Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF
Change from Baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score at LOCF was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. A participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score
Clinician-rated overall severity of depressive illness as assessed by CGI-C scale score was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity.
Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF
Number of participants with clinician-rated overall severity of depressive illness as assessed by CGI-C scale score at LOCF was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score
Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score was reported. The PHQ-9 is a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).
Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF
Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score at LOCF was reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27). LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score
Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire that has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores <=2 for each item and <= 6 for the total score are considered functional remission.
Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF
Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score at LOCF was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores <=2 for each item and <= 6 for the total score are considered functional remission. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score
Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 scale score was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status.
Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF
Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 domain scores at LOCF was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status. LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score
Change from baseline in participant-reported quality of life as assessed by QLDS total score was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition.
Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF
Change from baseline in participant-reported quality of life as assessed by QLDS total score at LOCF was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score: Health Status Index
Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health "today." Responses were used to generate health status index which ranges from 0 (dead) and 1 (full health), a lower score indicates worse health.
Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF
Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health "today." LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS
Change from baseline in participant-reported health status as assessed by EQ-5D-5L Score: VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement.
Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF
Change from baseline in participant-reported health status as assessed by EQ-5D-5L score: VAS at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire
Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Change From Baseline in Participant-reported Work Productivity as Assessed by WPAI: Depression Questionnaire at LOCF
Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire at LOCF was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs were those events if they started after administration of the first dose until 14 days after the last dose of study medication for other TEAEs except serious; and first dose until 30 days after the last dose of study medication for serious TEAEs.
Number of Participants With TEAEs of Special Interest
Number of participants with TEAEs of special interest were reported. It included significant TEAEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Events such as sedation, depersonalization/derealization disorder, depression suicidal, aggression, allergic cystitis, cholestasis and jaundice of hepatic origin, and many more were considered as TEAEs of special interest.
Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Number of participants with suicidal ideation or behavior as assessed by C-SSRS score was reported. The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Suicidal ideation consists of 5 items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior consists of 5 items: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and completed suicide. The maximum score (from the 10 categories) assigned for each participant was summarized into one of three broad categories: No suicidal ideation or behavior (0), Suicidal ideation (1 - 5), Suicidal behavior (6 - 10). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation and behavior.

Full Information

First Posted
April 6, 2020
Last Updated
October 23, 2023
Sponsor
Janssen-Cilag International NV
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1. Study Identification

Unique Protocol Identification Number
NCT04338321
Brief Title
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
Acronym
ESCAPE-TRD
Official Title
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag International NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.
Detailed Description
A depressive state with classical symptoms such as low (depressive/sad) mood, markedly diminished interest in activities, significant weight loss/gain, insomnia or hypersomnia, psychomotor agitation/retardation, excessive fatigue, inappropriate guilt, diminished concentration, and recurrent thoughts of death, persisting for more than 2 weeks is classified as major depressive disorder (MDD). The mechanism of action of ketamine is distinct from conventional antidepressants (ADs), which target the monoamines (serotonin, norepinephrine, and/or dopamine). Esketamine, the S-enantiomer of ketamine, is approved and widely used for the induction and maintenance of anesthesia via intramuscular or intravenous (IV) administration. There is a significant unmet need to develop novel AD treatments based on the relevant psychophysiological pathways underlying MDD. The goal of any novel treatment would be the rapid and long-lasting relief of depressive symptoms, especially in participants with treatment-resistant depression (TRD), who lack a sufficient response to the currently available treatment strategies. The study consists of a Screening Phase (up to 14 days), an Acute Phase (8 Weeks), a Maintenance Phase (24 Weeks) and a Safety Follow-up Phase (2 Weeks). Safety assessment includes adverse event, serious adverse events, physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, suicidal risk monitoring. The total duration of the study is approximately 36 Weeks for all participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
676 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esketamine Arm
Arm Type
Experimental
Arm Description
Participants will receive treatment with esketamine nasal spray (28 milligram [mg] [initial dose for elderly participants 65 to 74 years of age and adults of Japanese ancestry; may be used throughout the study in these populations; may be uptitrated in 28 mg increments], 56 mg [initial dose for adult participants aged 18 to 64 years and may be used for all age groups throughout the study], or 84 mg [maximum dose esketamine nasal spray may be uptitrated to]) twice-weekly with a flexible dose regimen from Day 1 until Week 4, once weekly from Week 5 to Week 8 and once-weekly or once every 2 weeks from Week 9 to Week 32 in combination with continuing serotonin-norepinephrine reuptake inhibitor/selective serotonin reuptake inhibitor (SSRI/SNRI).
Arm Title
Comparator Arm
Arm Type
Active Comparator
Arm Description
Participants will continue to take their current SSRI/SNRI augmented with quetiapine extended release (XR) as per the Summary of Product Characteristics (SmPC) (or local equivalent, if applicable). In adult participants aged 18 to 64 years, the initial dose is 50 mg/day on Days 1-2, 150 mg/day on Days 3-4 [lowest effective dose]; a further dose increase to 300 mg/day on Day 5 and onward will be based on individual participant evaluation. In elderly participants aged 65 to 74 years, the initial dose is 50 mg/day on Days 1-3, 100 mg/day on Days 4-7, and 150 mg/day on Day 8; a further dose increase to 300 mg/day will be based on individual participant evaluation no earlier than Day 22.
Intervention Type
Drug
Intervention Name(s)
Esketamine 28 mg
Intervention Description
Esketamine will be self-administered at a dose of 28 mg as nasal spray.
Intervention Type
Drug
Intervention Name(s)
Esketamine 56 mg
Intervention Description
Esketamine will be self-administered at a dose of 56 mg as nasal spray.
Intervention Type
Drug
Intervention Name(s)
Esketamine 84 mg
Intervention Description
Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR 50 mg
Intervention Description
Quetiapine XR will be administered at an initial dose of 50 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR 100 mg
Intervention Description
Quetiapine XR will be administered at a dose of 100 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
Intervention Type
Drug
Intervention Name(s)
Quetiapine XR 150 mg
Intervention Description
Quetiapine XR will be administered at a dose of 150 mg/day and may be further increased to 300 mg/day based on individual participant evaluation.
Intervention Type
Drug
Intervention Name(s)
SSRI/SNRI
Intervention Description
Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the SmPC (or local equivalent, if applicable).
Primary Outcome Measure Information:
Title
Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8
Description
Percentage of participants with remission as assessed by the MADRS at Week 8 was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. A participant was defined as being in remission if the MADRS total score was less than or equal to (<=)10 and no treatment or study discontinuation before Week 8.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32
Description
Percentage of participants with both remission at Week 8 and relapse-free until Week 32 were reported. A participant was defined as being in remission if the MADRS total score was <= 10 and no treatment or study discontinuation before Week 8. A relapse was defined by any of following: a) Worsening of depressive symptoms as indicated by MADRS total score greater than or equal to (>=) 22 confirmed by 1 additional assessment of MADRS total score >= 22 within the next 5 to 15 days. The date of the second MADRS assessment was used for the date of relapse; b) Any psychiatric hospitalization for: worsening of depression, suicide prevention or suicide attempt, the start date of hospitalization was the date of relapse; c) Suicide attempt, completed suicide, or any other clinically relevant event determined by investigator's judgment to be indicative of a relapse of depressive illness, but without hospitalized. The onset of the event was used for the date of relapse.
Time Frame
Week 32
Title
Change From Baseline in Clinician-rated Overall MADRS Score
Description
Change from baseline in clinician-rated overall MADRS score was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts.
Time Frame
Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)
Description
Change from baseline in clinician-rated overall MADRS score at LOCF was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score
Description
Change from baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF
Description
Change from Baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score at LOCF was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. A participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
Title
Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score
Description
Clinician-rated overall severity of depressive illness as assessed by CGI-C scale score was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
Title
Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF
Description
Number of participants with clinician-rated overall severity of depressive illness as assessed by CGI-C scale score at LOCF was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score
Description
Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score was reported. The PHQ-9 is a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27).
Time Frame
Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF
Description
Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score at LOCF was reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27). LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32
Title
Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score
Description
Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire that has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores <=2 for each item and <= 6 for the total score are considered functional remission.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF
Description
Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score at LOCF was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores <=2 for each item and <= 6 for the total score are considered functional remission. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score
Description
Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 scale score was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF
Description
Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 domain scores at LOCF was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status. LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score
Description
Change from baseline in participant-reported quality of life as assessed by QLDS total score was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF
Description
Change from baseline in participant-reported quality of life as assessed by QLDS total score at LOCF was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of "1" or "0". A score of "1" is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score: Health Status Index
Description
Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health "today." Responses were used to generate health status index which ranges from 0 (dead) and 1 (full health), a lower score indicates worse health.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF
Description
Change from baseline in participant-reported health-related quality of Life as assessed by EQ-5D-5L score: health status index at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument used to measure health outcomes, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (level 1 = no problem, level 2 = slight problems, level 3 = moderate problems, level 4 = severe problems, level 5 = extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health "today." LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS
Description
Change from baseline in participant-reported health status as assessed by EQ-5D-5L Score: VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF
Description
Change from baseline in participant-reported health status as assessed by EQ-5D-5L score: VAS at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire
Description
Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Change From Baseline in Participant-reported Work Productivity as Assessed by WPAI: Depression Questionnaire at LOCF
Description
Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire at LOCF was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward.
Time Frame
Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs were those events if they started after administration of the first dose until 14 days after the last dose of study medication for other TEAEs except serious; and first dose until 30 days after the last dose of study medication for serious TEAEs.
Time Frame
Up to Week 35
Title
Number of Participants With TEAEs of Special Interest
Description
Number of participants with TEAEs of special interest were reported. It included significant TEAEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Events such as sedation, depersonalization/derealization disorder, depression suicidal, aggression, allergic cystitis, cholestasis and jaundice of hepatic origin, and many more were considered as TEAEs of special interest.
Time Frame
Up to Week 35
Title
Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Description
Number of participants with suicidal ideation or behavior as assessed by C-SSRS score was reported. The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Suicidal ideation consists of 5 items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior consists of 5 items: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and completed suicide. The maximum score (from the 10 categories) assigned for each participant was summarized into one of three broad categories: No suicidal ideation or behavior (0), Suicidal ideation (1 - 5), Suicidal behavior (6 - 10). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation and behavior.
Time Frame
Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At screening, each participant must meet Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features, based on clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI) At screening and baseline, each participant must have an Inventory of Depressive Symptomatology - Clinician-rated, 30 item (IDS-C30) total score of greater than or equal to (>=) 34 Must be on a current antidepressive treatment that includes an selective serotonin reuptake inhibitor (SSRI)/ serotonin-norepinephrine reuptake inhibitor (SNRI) at screening that resulted in nonresponse (less than 25% improvement of symptoms) after having been given at an adequate dosage (based on antidepressive dosages from SmPC [or local equivalent, if applicable]) for an adequate duration of at least 6 weeks and having been uptitrated to the maximum tolerated dose; however, at screening the participant must show signs of minimal clinical improvement to be eligible for the study. Clinical improvement of a participant on their current AD treatment will be retrospectively evaluated in a qualified psychiatric interview performed by an experienced clinician. At baseline (Day 1) prior to randomization, the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current AD treatment are still met (that is nonresponse and minimal clinical improvement) The current antidepressive treatment, was immediately preceded by nonresponse to at least 1 but not more than 5 different, consecutive treatments (all within the current moderate to severe antidepressive episode) with anti-depressants (ADs) taken at an adequate dosage for an adequate duration of at least 6 weeks and must be documented Must have been treated with at least 2 different antidepressive substance classes among the treatments taken at an adequate dosage for an adequate duration of at least 6 weeks resulting in nonresponse in the current moderate to severe depressive episode (including the current treatment with an selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor [SSRI/SNRI]) Must be on a single oral SSRI/SNRI on Day 1 prior to randomization Exclusion Criteria: Received treatment with esketamine or ketamine in the current moderate to severe depressive episode Received treatment with quetiapine extended- or immediate-release in the current moderate to severe depressive episode of a dose higher than 50 milligram per day (mg/day) Had depressive symptoms in the current moderate to severe depressive episode that previously did not respond to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT Has no signs of clinical improvement at all or with a significant improvement on their current AD treatment that includes an SSRI/SNRI as determined at screening by an experienced clinician during the qualified psychiatric interview Received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the Mini International Neuropsychiatric Interview [MINI]), obsessive compulsive disorder (current only), intellectual disability (DSM-5 diagnostic codes 317, 318.0, 318.1, 318.2, 315.8, and 319), autism spectrum disorder, borderline personality disorder, or antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder age at onset of first episode of MDD was more than or equal to (>=) 55 years has homicidal ideation or intent, per the investigator's clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to screening, per the investigator's clinical judgment; or based on the Columbia-Suicide Severity Rating Scale (C-SSRS), corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation, or a history of suicidal behavior within the past year prior to screening. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the acute phase should also be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag International NV Clinical Trials
Organizational Affiliation
Janssen-Cilag International NV
Official's Role
Study Director
Facility Information:
Facility Name
FunDaMos
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1405BOA
Country
Argentina
Facility Name
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
City
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1133AAH
Country
Argentina
Facility Name
CEN-Consultorios Especializados en Neurociencias
City
Cordoba
ZIP/Postal Code
5000FJF
Country
Argentina
Facility Name
Fundacion Lennox
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Instituto Médico DAMIC
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Sanatorio Prof. Leon S. Morra S.A
City
Cordoba
ZIP/Postal Code
X5009BIN
Country
Argentina
Facility Name
Instituto de Neurociencias San Agustín
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Schmitz and Schmitz
City
Vienna
ZIP/Postal Code
1010
Country
Austria
Facility Name
Medical University Vienna, MUV
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Anima
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Facility Name
Pz Duffel
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
Clinique Psychiatrique des Frères Alexiens
City
Henri-Chapelle
ZIP/Postal Code
4841
Country
Belgium
Facility Name
Sint-Franciskusziekenhuis
City
Heusden-Zolder
ZIP/Postal Code
3550
Country
Belgium
Facility Name
ARIADNE
City
Lede
ZIP/Postal Code
9340
Country
Belgium
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CPN - Centro de Pesquisa em Neurociências Ltda
City
Belo Horizonte
ZIP/Postal Code
30150-270
Country
Brazil
Facility Name
Trial Tech Tecnologia em Pesquisas com Medicamentos
City
Curitiba
ZIP/Postal Code
80240-280
Country
Brazil
Facility Name
Ruschel Medicina e Pesquisa Clínica Ltda
City
Rio de Janeiro
ZIP/Postal Code
22270-060
Country
Brazil
Facility Name
C.J.S. Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)
City
São Paulo
ZIP/Postal Code
04020-060
Country
Brazil
Facility Name
BR Trials
City
São Paulo
ZIP/Postal Code
05003-090
Country
Brazil
Facility Name
State Psychiatric Hospital Kardzhali
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Mental Health Center - Plovdiv
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Mental Health Center - Rousse
City
Rousse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
MHC - Sofia, EOOD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Centre for Mental Health Prof.N.Shipkovenski EOOD
City
Sofia
ZIP/Postal Code
1377
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Psychiatricka ambulance Saint Anne s.r.o.
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
Psychiatricka ambulance, MUDr. Marta Holanova
City
Brno
ZIP/Postal Code
61500
Country
Czechia
Facility Name
NeuropsychiatrieHK, s.r.o.
City
Hradec Kralove-Vekose
ZIP/Postal Code
50341
Country
Czechia
Facility Name
A-Shine s.r.o.
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Facility Name
Institut Neuropsychiatricke pece
City
Prague
ZIP/Postal Code
18600
Country
Czechia
Facility Name
Clintrial s.r.o.
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Facility Name
AD71 s.r.o.
City
Praha 10
ZIP/Postal Code
109 00
Country
Czechia
Facility Name
Medical Services Prague s.r.o.
City
Praha 6
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Psykiatrien i Region Syddanmark
City
Esbjerg N
ZIP/Postal Code
6715
Country
Denmark
Facility Name
Mederon LTD at ARTES
City
Helsinki
ZIP/Postal Code
00270
Country
Finland
Facility Name
Psykiatrinen Palvelukeskus Solvum Oy
City
Helsinki
ZIP/Postal Code
120
Country
Finland
Facility Name
Savon Psykiatripalvelu
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Universitaetsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Rheinhessen Fachklinik Alzey
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Medizinisches Versorgungszentrum LiO GmbH
City
Berlin
ZIP/Postal Code
12209
Country
Germany
Facility Name
Alexander Schulze - Germany
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
Praxis Dr. med. Kirsten Hahn
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
Vivantes Klinikum Spandau
City
Berlin
ZIP/Postal Code
13585
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09131
Country
Germany
Facility Name
Carl-Thiem-Klinikum Cottbus gGmbH
City
Cottbus
ZIP/Postal Code
3048
Country
Germany
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
ZIP/Postal Code
44287
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carcus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt Am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
SRH Waldklinikum Gera GmbH
City
Gera
ZIP/Postal Code
7548
Country
Germany
Facility Name
Georg-August Universität, Universitätsmedizin Göttingen
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Evangelisches Krankenhaus Bethanien gGmbH
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Facility Name
Universitaetsklinik Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Klinische Forschung Hamburg
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Klinische Forschung Hannover-Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universität Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Oberhavel Kliniken GmbH
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
7743
Country
Germany
Facility Name
Panakeia - Arzneimittelforschung GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Universitaetsklinikum Magdeburg A.oe.R
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz GmbH
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Munster
ZIP/Postal Code
48147
Country
Germany
Facility Name
Ruppiner Kliniken
City
Neuruppin
ZIP/Postal Code
16816
Country
Germany
Facility Name
Praxis Prof. Steinwachs
City
Nurnberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Johanniter Krankenhaus Oberhausen
City
Oberhausen
ZIP/Postal Code
46145
Country
Germany
Facility Name
Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik
City
Pfaffenhofen
ZIP/Postal Code
85276
Country
Germany
Facility Name
Somni Bene GmbH
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany
City
Stralsund
ZIP/Postal Code
18437
Country
Germany
Facility Name
Aiginition Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
'Dafni' Psychiatric Hospital of Attica
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Venizeleio General Hospital
City
Crete
ZIP/Postal Code
71409
Country
Greece
Facility Name
Psychiatric Clinic 'Agios Charalampos'
City
Heraklion
ZIP/Postal Code
71305
Country
Greece
Facility Name
University General Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45110
Country
Greece
Facility Name
University General Hospital of Rio Patras
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
424 Military Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Psychiatric Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56430
Country
Greece
Facility Name
'G. Papanikolaou' Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Processus Kft.
City
Budapest
ZIP/Postal Code
1137
Country
Hungary
Facility Name
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
City
Kalocsa
ZIP/Postal Code
6300
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
ZIP/Postal Code
45100
Country
Israel
Facility Name
Beer Yaakov Mental Health Center
City
Lod
ZIP/Postal Code
7129434
Country
Israel
Facility Name
Geha Mental Health Center
City
Petach Tikva
ZIP/Postal Code
4910002
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Telaviv
ZIP/Postal Code
6423914
Country
Israel
Facility Name
Republican Scientific and Practical Center of Mental Health
City
Almaty
ZIP/Postal Code
50012
Country
Kazakhstan
Facility Name
Medical Center for Psychological Healt SME
City
Nur-Sultan
Country
Kazakhstan
Facility Name
East-Kazakhstan Regional Centre of Mental Health
City
Ust'-Kamenogorsk
ZIP/Postal Code
70016
Country
Kazakhstan
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
ZIP/Postal Code
570-711
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
ZIP/Postal Code
30990
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Hospital Pengajar Universiti Putra Malaysia
City
Serdang
ZIP/Postal Code
43400
Country
Malaysia
Facility Name
Hospital Tuanku Jaafar
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Brain Research Center
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Haukeland University Hospital
City
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sykehuset Ostfold
City
Moss
ZIP/Postal Code
1535
Country
Norway
Facility Name
St Olav University Hospital
City
Trondheim
ZIP/Postal Code
7000
Country
Norway
Facility Name
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Osrodek Badan Klinicznych CLINSANTE S.C.
City
Bydgoszcz
ZIP/Postal Code
85-794
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Centrum Badań Klinicznych PI-House sp. z o.o.
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Centrum Medyczne Care Clinic Katowice
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
Facility Name
Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego
City
Lodz
ZIP/Postal Code
91-229
Country
Poland
Facility Name
SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych
City
Lodz
ZIP/Postal Code
92-216
Country
Poland
Facility Name
Centrum Medyczne Luxmed Sp z o o
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
Osrodek Badan Klinicznych CLINSANTE S.C.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa
City
Guilhufe - Penafiel
ZIP/Postal Code
4564-007
Country
Portugal
Facility Name
Fundação Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital CUF Tejo
City
Lisbon
ZIP/Postal Code
1350-352
Country
Portugal
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Cape Town Clinical Research Centre
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Flexivest 14 Research
City
Cape Town
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Gert Bosch - Pretoria South Africa
City
Garsfontein
ZIP/Postal Code
00 45
Country
South Africa
Facility Name
Psykiatriska kliniken
City
Goteborg
ZIP/Postal Code
41717
Country
Sweden
Facility Name
Affecta Pskyiatrimottagning
City
Halmstad
ZIP/Postal Code
SE-30248
Country
Sweden
Facility Name
Psykiatriska kliniken
City
Lulea
ZIP/Postal Code
97180
Country
Sweden
Facility Name
ProbarE i Lund AB
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Facility Name
ONE LIFETIME Läkarmottagning
City
Skovde
ZIP/Postal Code
SE-54150
Country
Sweden
Facility Name
ProbarE i Stockholm AB
City
Stockholm
ZIP/Postal Code
113 29
Country
Sweden
Facility Name
Changhua Christian Hospital
City
ChangHua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Hualien Tzu Chi Hospital
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
Kai-Syuan Psychiatric Hospital
City
Kaohsiung
ZIP/Postal Code
80276
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83342
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Taipei Medical University
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
ZIP/Postal Code
16285
Country
Turkey
Facility Name
Uludag University Medical Faculty
City
Bursa
ZIP/Postal Code
16285
Country
Turkey
Facility Name
Bakirkoy Mental Health Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Erenkoy Mental Health Hospital
City
Istanbul
ZIP/Postal Code
34736
Country
Turkey
Facility Name
Uskudar University Neuropsychiatry Hospital
City
Istanbul
ZIP/Postal Code
34768
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
34371
Country
Turkey
Facility Name
Selcuk University Medical Faculty
City
Konya
ZIP/Postal Code
42130
Country
Turkey
Facility Name
Liv Hospital
City
Samsun
ZIP/Postal Code
55020
Country
Turkey
Facility Name
Namik Kemal University
City
Tekirdag
ZIP/Postal Code
59030
Country
Turkey
Facility Name
American Center for Psychiatry and Neurology
City
Abu Dhabi
ZIP/Postal Code
51133
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

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