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

PHASE3CompletedINTERVENTIONAL
Enrollment

676

Participants

Timeline

Start Date

August 21, 2020

Primary Completion Date

January 20, 2022

Study Completion Date

July 15, 2022

Conditions
Depressive Disorder, Major
Interventions
DRUG

Esketamine 28 mg

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

DRUG

Esketamine 56 mg

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

DRUG

Esketamine 84 mg

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

DRUG

Quetiapine XR 50 mg

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.

DRUG

Quetiapine XR 100 mg

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.

DRUG

Quetiapine XR 150 mg

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.

DRUG

SSRI/SNRI

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).

Trial Locations (171)

110

Taipei Medical University, Taipei

120

Psykiatrinen Palvelukeskus Solvum Oy, Helsinki

333

Chang Gung Memorial Hospital, Taoyuan District

500

Changhua Christian Hospital, Changhua

970

Hualien Tzu Chi Hospital, Hualien City

1010

Schmitz and Schmitz, Vienna

1083

Semmelweis Egyetem, Budapest

1090

Medical University Vienna MUV, Vienna

1113

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum, Sofia

1125

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

1137

Processus Kft, Budapest

1202

MHC - Sofia, EOOD, Sofia

1377

Centre for Mental Health Prof.N.Shipkovenski EOOD, Sofia

1431

University Multiprofile Hospital for Active Treatment - UMHAT Alexandrovska EAD, Sofia

1535

Sykehuset Ostfold, Moss

1900

Instituto de Neurociencias San Agustin, La Plata

2000

C I A P Centro de investigacion y Asistencia en Psiquiatria, Rosario

2570

Pz Duffel, Duffel

3048

Carl-Thiem-Klinikum Cottbus gGmbH, Cottbus

3200

Bugat Pal Korhaz, Gyöngyös

3550

Sint-Franciskusziekenhuis, Heusden-Zolder

3570

Anima, Alken

4000

CHU de Liege, Liège

4002

Mental Health Center - Plovdiv, Plovdiv

4031

Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház, Debrecen

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4841

Clinique Psychiatrique des Frères Alexiens, Henri-Chapelle

5000

Fundacion Lennox, Córdoba

5021

Haukeland University Hospital, Hordaland

5800

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

6100

Hacettepe University Medical Faculty, Ankara

6300

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

6600

State Psychiatric Hospital Kardzhali, Kardzhali

6715

Psykiatrien i Region Syddanmark, Esbjerg N

7000

St Olav University Hospital, Trondheim

7003

Mental Health Center - Rousse, Rousse

7530

Cape Town Clinical Research Centre, Cape Town

7548

SRH Waldklinikum Gera GmbH, Gera

7550

Flexivest 14 Research, Cape Town

7623

Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs

7743

Universitatsklinikum Jena, Jena

8036

Medical University Graz, Graz

9000

Aalborg University Hospital, Aalborg

9340

ARIADNE, Lede

10000

Clintrial s r o, Prague

10002

National Taiwan University Hospital, Taipei

10449

Mackay Memorial Hospital, Taipei

10629

Emovis GmbH, Berlin

11217

Taipei Veterans General Hospital, Taipei

11528

Aiginition Hospital of Athens, Athens

12203

Charite Campus Benjamin Franklin, Berlin

12209

Medizinisches Versorgungszentrum LiO GmbH, Berlin

13156

Alexander Schulze - Germany, Berlin

13187

Praxis Dr. med. Kirsten Hahn, Berlin

13585

Vivantes Klinikum Spandau, Berlin

16000

Medical Services Prague S R O, Prague

16285

Bursa Yuksek Ihtisas Training and Research Hospital, Bursa

Uludag University Medical Faculty, Bursa

16761

Oberhavel Kliniken GmbH, Hennigsdorf

16816

Ruppiner Kliniken, Neuruppin

17489

Evangelisches Krankenhaus Bethanien gGmbH, Greifswald

18437

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

18600

Institut Neuropsychiatricke pece, Prague

19053

Somni Bene GmbH, Schwerin

19055

Klinische Forschung Schwerin GmbH, Schwerin

20251

Universitaetsklinik Hamburg-Eppendorf, Hamburg

20253

Klinische Forschung Hamburg, Hamburg

22222

ProbarE i Lund AB, Lund

26504

University General Hospital of Rio Patras, Pátrai

30159

Klinische Forschung Hannover-Mitte GmbH, Hanover

30625

Medizinische Hochschule Hannover, Hanover

30990

Hospital Raja Permaisuri Bainun, Ipoh

31200

A Shine S R O, Pilsen

34147

Bakirkoy Mental Health Training and Research Hospital, Istanbul

34371

Ege Universitesi Tip Fakultesi, Izmir

34736

Erenkoy Mental Health Hospital, Istanbul

34768

Uskudar University Neuropsychiatry Hospital, Istanbul

37075

Georg August Universitat Universitatsmedizin Gottingen, Göttingen

39120

Universitaetsklinikum Magdeburg A.oe.R, Magdeburg

41717

Psykiatriska kliniken, Gothenburg

42130

Selcuk University Medical Faculty, Konya

43400

Hospital Pengajar Universiti Putra Malaysia, Serdang

44287

Klinikum Dortmund gGmbH, Dortmund

45100

Shalvata Mental Health Center, Hod HaSharon

45110

University General Hospital of Ioannina, Ioannina

46145

Johanniter Krankenhaus Oberhausen, Oberhausen

48147

Universitatsklinikum Munster, Münster

50012

Republican Scientific and Practical Center of Mental Health, Almaty

50341

NeuropsychiatrieHK, s.r.o., Hradec Kralove-Vekose

50586

Hospital Kuala Lumpur, Kuala Lumpur

51133

American Center for Psychiatry and Neurology, Abu Dhabi

52074

Universitaetsklinikum der RWTH Aachen, Aachen

52621

Sheba Medical Center, Ramat Gan

53105

Universitatsklinikum Bonn, Bonn

54636

424 Military Hospital of Thessaloniki, Thessaloniki

55020

Liv Hospital, Samsun

55131

Universitatsmedizin der Johannes Gutenberg Universitat Mainz, Mainz

55232

Rheinhessen Fachklinik Alzey, Alzey

56430

Psychiatric Hospital of Thessaloniki, Thessaloniki

57010

G Papanikolaou Hospital of Thessaloniki, Thessaloniki

59030

Namik Kemal University, Tekirdağ

59100

University Malaya Medical Centre, Kuala Lumpur

60200

Psychiatricka ambulance Saint Anne s.r.o., Brno

60528

Universitatsklinikum Frankfurt, Frankfurt am Main

61469

Chonnam National University Hospital, Gwangju

61500

Psychiatricka ambulance, MUDr. Marta Holanova, Brno

66421

Universitätsklinikum des Saarlandes, Homburg

69115

Universität Heidelberg, Heidelberg

70016

East-Kazakhstan Regional Centre of Mental Health, Ust-Kamenogorsk

70110

Savon Psykiatripalvelu, Kuopio

70300

Hospital Tuanku Jaafar, Seremban

70403

National Cheng Kung University Hospital, Tainan City

71305

Psychiatric Clinic 'Agios Charalampos', Heraklion

71409

Venizeleio General Hospital, Crete

79104

Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik, Freiburg im Breisgau

80276

Kai-Syuan Psychiatric Hospital, Kaohsiung City

83342

Chang Gung Memorial Hospital, Kaohsiung City

85276

Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik, Pfaffenhofen

90402

Praxis Prof. Steinwachs, Nuremberg

97180

Psykiatriska kliniken, Luleå

3109601

Rambam Medical Center, Haifa

4910002

Geha Mental Health Center, Petah Tikva

6423914

Tel Aviv Sourasky Medical Center, Telaviv

7129434

Beer Yaakov Mental Health Center, Lod

C1133AAH

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales, Buenos Aires

C1405BOA

FunDaMos, Buenos Aires

5000FJF

CEN Consultorios Especializados en Neurociencias, Córdoba

X5003DCE

Instituto Medico DAMIC, Córdoba

X5009BIN

Sanatorio Prof Leon S Morra S A, Córdoba

30150-270

CPN - Centro de Pesquisa em Neurociências Ltda, Belo Horizonte

80240-280

Trial Tech Tecnologia em Pesquisas com Medicamentos, Curitiba

22270 060

Ruschel Medicina e Pesquisa Clínica Ltda, Rio de Janeiro

04020-060

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

05003-090

BR Trials, São Paulo

109 00

AD71 s.r.o., Prague

00270

Mederon LTD at ARTES, Helsinki

09131

Klinikum Chemnitz gGmbH, Chemnitz

01307

Universitatsklinikum Carl Gustav Carcus Dresden, Dresden

04275

Panakeia - Arzneimittelforschung GmbH, Leipzig

09648

Pharmakologisches Studienzentrum Chemnitz GmbH, Mittweida

124 62

'Dafni' Psychiatric Hospital of Attica, Athens

H-9024

Petz Aladar Megyei Oktato Korhaz, Győr

Unknown

Medical Center for Psychological Healt SME, Nur-Sultan

1081 GN

Brain Research Center, Amsterdam

1105 AZ

AMC, Amsterdam

2300 RC

LUMC, Leiden

15-404

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk, Bialystok

85 794

Osrodek Badan Klinicznych CLINSANTE S C, Bydgoszcz

80 214

Uniwersyteckie Centrum Kliniczne, Gdansk

80 546

Centrum Badan Klinicznych PI House sp z o o, Gdansk

40-568

Centrum Medyczne Care Clinic Katowice, Katowice

64-100

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS, Leszno

91-229

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

92-216

SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych, Lodz

20 109

Centrum Medyczne Luxmed Sp z o o, Lublin

87 100

Osrodek Badan Klinicznych CLINSANTE S C, Torun

4710-243

Hospital de Braga, Braga

4564-007

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

1350-352

Hosp. Cuf Tejo, Lisbon

1400 038

Fund. Champalimaud, Lisbon

1649-035

Centro Hospitalar de Lisboa Norte Hospital Santa Maria, Lisbon

2674-514

Uls Loures Odivelas - Hosp. Loures, Loures

00 45

Gert Bosch Pretoria South Africa, Garsfontein

570 711

Wonkwang University Hospital, Iksan

02447

KyungHee University Hospital, Seoul

02841

Korea University Anam Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

SE-30248

Affecta Pskyiatrimottagning, Halmstad

SE-54150

ONE LIFETIME Lakarmottagning, Skövde

113 29

ProbarE i Stockholm AB, Stockholm

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT04338321 - 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 | Biotech Hunter | Biotech Hunter