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

NCT04338321 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CR1087872019-002992-3354135419TRD3013
• Study Type: interventional
• Target: 676
• Locations: 24 countries
• Sites: 171

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 8

Secondary Outcomes (24)

• Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32

  Week 32

• Change From Baseline in Clinician-rated Overall MADRS Score

  Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

• Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)

  Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

• Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score

  Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

• Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF

  Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

Study Arms (2)

Esketamine Arm

EXPERIMENTAL

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).

Drug: Esketamine 28 mg; Drug: Esketamine 56 mg; Drug: Esketamine 84 mg; Drug: SSRI/SNRI

Comparator Arm

ACTIVE COMPARATOR

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.

Drug: Quetiapine XR 50 mg; Drug: Quetiapine XR 100 mg; Drug: Quetiapine XR 150 mg; Drug: SSRI/SNRI

Interventions

Esketamine 28 mg DRUG

Esketamine will be self-administered at a dose of 28 mg as nasal spray.

Esketamine Arm

Esketamine 56 mg DRUG

Esketamine will be self-administered at a dose of 56 mg as nasal spray.

Esketamine Arm

Esketamine 84 mg DRUG

Esketamine will be self-administered at a dose of 84 mg (maximum uptitrated dose) as nasal spray.

Esketamine Arm

Quetiapine XR 50 mg DRUG

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.

Comparator Arm

Quetiapine XR 100 mg DRUG

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.

Comparator Arm

Quetiapine XR 150 mg DRUG

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.

Comparator Arm

SSRI/SNRI DRUG

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).

Comparator Arm; Esketamine Arm

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (171)

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, C1133AAH, Argentina

Location

FunDaMos

Buenos Aires, C1405BOA, Argentina

Location

CEN Consultorios Especializados en Neurociencias

Córdoba, 5000FJF, Argentina

Location

Fundacion Lennox

Córdoba, 5000, Argentina

Location

Instituto Medico DAMIC

Córdoba, X5003DCE, Argentina

Location

Sanatorio Prof Leon S Morra S A

Córdoba, X5009BIN, Argentina

Location

Instituto de Neurociencias San Agustin

La Plata, 1900, Argentina

Location

C I A P Centro de investigacion y Asistencia en Psiquiatria

Rosario, 2000, Argentina

Location

Medical University Graz

Graz, 8036, Austria

Location

Schmitz and Schmitz

Vienna, 1010, Austria

Location

Medical University Vienna MUV

Vienna, 1090, Austria

Location

Anima

Alken, 3570, Belgium

Location

Pz Duffel

Duffel, 2570, Belgium

Location

Clinique Psychiatrique des Frères Alexiens

Henri-Chapelle, 4841, Belgium

Location

Sint-Franciskusziekenhuis

Heusden-Zolder, 3550, Belgium

Location

ARIADNE

Lede, 9340, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

CPN - Centro de Pesquisa em Neurociências Ltda

Belo Horizonte, 30150-270, Brazil

Location

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, 80240-280, Brazil

Location

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, 22270 060, Brazil

Location

C J S Carvalho & Carvalho LTDA (Viver - Centro De Desospitalizacao Humana)

São Paulo, 04020-060, Brazil

Location

BR Trials

São Paulo, 05003-090, Brazil

Location

State Psychiatric Hospital Kardzhali

Kardzhali, 6600, Bulgaria

Location

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, 5800, Bulgaria

Location

Mental Health Center - Plovdiv

Plovdiv, 4002, Bulgaria

Location

Mental Health Center - Rousse

Rousse, 7003, Bulgaria

Location

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

Sofia, 1113, Bulgaria

Location

MHC - Sofia, EOOD

Sofia, 1202, Bulgaria

Location

Centre for Mental Health Prof.N.Shipkovenski EOOD

Sofia, 1377, Bulgaria

Location

University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD

Sofia, 1431, Bulgaria

Location

Psychiatricka ambulance Saint Anne s.r.o.

Brno, 60200, Czechia

Location

Psychiatricka ambulance, MUDr. Marta Holanova

Brno, 61500, Czechia

Location

NeuropsychiatrieHK, s.r.o.

Hradec Kralove-Vekose, 50341, Czechia

Location

A Shine S R O

Pilsen, 31200, Czechia

Location

Clintrial s r o

Prague, 10000, Czechia

Location

AD71 s.r.o.

Prague, 109 00, Czechia

Location

Medical Services Prague S R O

Prague, 16000, Czechia

Location

Institut Neuropsychiatricke pece

Prague, 18600, Czechia

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Psykiatrien i Region Syddanmark

Esbjerg N, 6715, Denmark

Location

Mederon LTD at ARTES

Helsinki, 00270, Finland

Location

Psykiatrinen Palvelukeskus Solvum Oy

Helsinki, 120, Finland

Location

Savon Psykiatripalvelu

Kuopio, 70110, Finland

Location

Universitaetsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Rheinhessen Fachklinik Alzey

Alzey, 55232, Germany

Location

Emovis GmbH

Berlin, 10629, Germany

Location

Charite Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Medizinisches Versorgungszentrum LiO GmbH

Berlin, 12209, Germany

Location

Alexander Schulze - Germany

Berlin, 13156, Germany

Location

Praxis Dr. med. Kirsten Hahn

Berlin, 13187, Germany

Location

Vivantes Klinikum Spandau

Berlin, 13585, Germany

Location

Universitatsklinikum Bonn

Bonn, 53105, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09131, Germany

Location

Carl-Thiem-Klinikum Cottbus gGmbH

Cottbus, 3048, Germany

Location

Klinikum Dortmund gGmbH

Dortmund, 44287, Germany

Location

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60528, Germany

Location

Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik

Freiburg im Breisgau, 79104, Germany

Location

SRH Waldklinikum Gera GmbH

Gera, 7548, Germany

Location

Georg August Universitat Universitatsmedizin Gottingen

Göttingen, 37075, Germany

Location

Evangelisches Krankenhaus Bethanien gGmbH

Greifswald, 17489, Germany

Location

Universitaetsklinik Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Klinische Forschung Hamburg

Hamburg, 20253, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, 30159, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universität Heidelberg

Heidelberg, 69115, Germany

Location

Oberhavel Kliniken GmbH

Hennigsdorf, 16761, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitatsklinikum Jena

Jena, 7743, Germany

Location

Panakeia - Arzneimittelforschung GmbH

Leipzig, 04275, Germany

Location

Universitaetsklinikum Magdeburg A.oe.R

Magdeburg, 39120, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH

Mittweida, 09648, Germany

Location

Universitatsklinikum Munster

Münster, 48147, Germany

Location

Ruppiner Kliniken

Neuruppin, 16816, Germany

Location

Praxis Prof. Steinwachs

Nuremberg, 90402, Germany

Location

Johanniter Krankenhaus Oberhausen

Oberhausen, 46145, Germany

Location

Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik

Pfaffenhofen, 85276, Germany

Location

Somni Bene GmbH

Schwerin, 19053, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Klinikum der Hansestadt Stralsund GmbH-Ambulanz-Klinik für Psychiatrie und Psychotherapie - Germany

Stralsund, 18437, Germany

Location

Aiginition Hospital of Athens

Athens, 11528, Greece

Location

'Dafni' Psychiatric Hospital of Attica

Athens, 124 62, Greece

Location

Venizeleio General Hospital

Crete, 71409, Greece

Location

Psychiatric Clinic 'Agios Charalampos'

Heraklion, 71305, Greece

Location

University General Hospital of Ioannina

Ioannina, 45110, Greece

Location

University General Hospital of Rio Patras

Pátrai, 26504, Greece

Location

424 Military Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

Psychiatric Hospital of Thessaloniki

Thessaloniki, 56430, Greece

Location

G Papanikolaou Hospital of Thessaloniki

Thessaloniki, 57010, Greece

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

Budapest, 1125, Hungary

Location

Processus Kft

Budapest, 1137, Hungary

Location

Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház

Debrecen, 4031, Hungary

Location

Bugat Pal Korhaz

Gyöngyös, 3200, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, H-9024, Hungary

Location

Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

Kalocsa, 6300, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, 7623, Hungary

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Shalvata Mental Health Center

Hod HaSharon, 45100, Israel

Location

Beer Yaakov Mental Health Center

Lod, 7129434, Israel

Location

Geha Mental Health Center

Petah Tikva, 4910002, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Telaviv, 6423914, Israel

Location

Republican Scientific and Practical Center of Mental Health

Almaty, 50012, Kazakhstan

Location

Medical Center for Psychological Healt SME

Nur-Sultan, Kazakhstan

Location

East-Kazakhstan Regional Centre of Mental Health

Ust-Kamenogorsk, 70016, Kazakhstan

Location

Hospital Raja Permaisuri Bainun

Ipoh, 30990, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Pengajar Universiti Putra Malaysia

Serdang, 43400, Malaysia

Location

Hospital Tuanku Jaafar

Seremban, 70300, Malaysia

Location

Brain Research Center

Amsterdam, 1081 GN, Netherlands

Location

AMC

Amsterdam, 1105 AZ, Netherlands

Location

LUMC

Leiden, 2300 RC, Netherlands

Location

Haukeland University Hospital

Hordaland, 5021, Norway

Location

Sykehuset Ostfold

Moss, 1535, Norway

Location

St Olav University Hospital

Trondheim, 7000, Norway

Location

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, 15-404, Poland

Location

Osrodek Badan Klinicznych CLINSANTE S C

Bydgoszcz, 85 794, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Centrum Medyczne Care Clinic Katowice

Katowice, 40-568, Poland

Location

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, 64-100, Poland

Location

Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego

Lodz, 91-229, Poland

Location

SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych

Lodz, 92-216, Poland

Location

Centrum Medyczne Luxmed Sp z o o

Lublin, 20 109, Poland

Location

Osrodek Badan Klinicznych CLINSANTE S C

Torun, 87 100, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Centro Hospitalar do Tâmega e Sousa, EPE - Hospital Padre Americo, Vale do Sousa

Guilhufe - Penafiel, 4564-007, Portugal

Location

Hosp. Cuf Tejo

Lisbon, 1350-352, Portugal

Location

Fund. Champalimaud

Lisbon, 1400 038, Portugal

Location

Centro Hospitalar de Lisboa Norte Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Uls Loures Odivelas - Hosp. Loures

Loures, 2674-514, Portugal

Location

Cape Town Clinical Research Centre

Cape Town, 7530, South Africa

Location

Flexivest 14 Research

Cape Town, 7550, South Africa

Location

Gert Bosch Pretoria South Africa

Garsfontein, 00 45, South Africa

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Wonkwang University Hospital

Iksan, 570 711, South Korea

Location

KyungHee University Hospital

Seoul, 02447, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Psykiatriska kliniken

Gothenburg, 41717, Sweden

Location

Affecta Pskyiatrimottagning

Halmstad, SE-30248, Sweden

Location

Psykiatriska kliniken

Luleå, 97180, Sweden

Location

ProbarE i Lund AB

Lund, 22222, Sweden

Location

ONE LIFETIME Lakarmottagning

Skövde, SE-54150, Sweden

Location

ProbarE i Stockholm AB

Stockholm, 113 29, Sweden

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

Kai-Syuan Psychiatric Hospital

Kaohsiung City, 80276, Taiwan

Location

Chang Gung Memorial Hospital

Kaohsiung City, 83342, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Hacettepe University Medical Faculty

Ankara, 6100, Turkey (Türkiye)

Location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16285, Turkey (Türkiye)

Location

Uludag University Medical Faculty

Bursa, 16285, Turkey (Türkiye)

Location

Bakirkoy Mental Health Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Erenkoy Mental Health Hospital

Istanbul, 34736, Turkey (Türkiye)

Location

Uskudar University Neuropsychiatry Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi

Izmir, 34371, Turkey (Türkiye)

Location

Selcuk University Medical Faculty

Konya, 42130, Turkey (Türkiye)

Location

Liv Hospital

Samsun, 55020, Turkey (Türkiye)

Location

Namik Kemal University

Tekirdağ, 59030, Turkey (Türkiye)

Location

American Center for Psychiatry and Neurology

Abu Dhabi, 51133, United Arab Emirates

Location

Related Publications (3)

• Lan CH, Wei JC. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93-94. doi: 10.1056/NEJMc2313230. No abstract available.

  PMID: 38169503 DERIVED

• Horowitz MA, Ploderl M, Naudet F. Esketamine Nasal Spray versus Quetiapine for Resistant Depression. N Engl J Med. 2024 Jan 4;390(1):93. doi: 10.1056/NEJMc2313230. No abstract available.

  PMID: 38169502 DERIVED

• Reif A, Bitter I, Buyze J, Cebulla K, Frey R, Fu DJ, Ito T, Kambarov Y, Llorca PM, Oliveira-Maia AJ, Messer T, Mulhern-Haughey S, Rive B, von Holt C, Young AH, Godinov Y; ESCAPE-TRD Investigators. Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression. N Engl J Med. 2023 Oct 5;389(14):1298-1309. doi: 10.1056/NEJMoa2304145.

  PMID: 37792613 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

To minimize potential bias, the Montgomery-Asberg Depression Rating Scale (MADRS) was performed by an independent on-site rater who was blinded to the participant's treatment, and who was not involved in any other study assessments or treatment decisions.

Results Point of Contact

• Title: Europe, Middle East, Africa (EMEA) Medical Advisor Spravato
• Organization: Janssen-Cilag International NV

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen-Cilag International NV Clinical Trials

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: August 21, 2020
• Primary Completion: January 20, 2022
• Study Completion: July 15, 2022
• Last Updated: April 29, 2025
• Results First Posted: February 15, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); IL (6); KA (3); KR (6); PT (6); BE (6); DK (2); NL (3); TW (10); FI (3); DE (38); MY (5); BU (8); GR (9); CZ (8); TU (10); ZA (3); HU (9); AR (8); PL (10); AE (1); SE (6); BR (5); NO (3)