A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

183

Participants

Timeline

Start Date

April 26, 2021

Primary Completion Date

July 22, 2024

Study Completion Date

July 22, 2024

Conditions
Depressive Disorder, Major
Interventions
DRUG

Esketamine

Esketamine will be self-administered as nasal spray.

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 summary of product characteristics (SmPC) (or local equivalent, if applicable). During this LTE study, investigators will be allowed to switch individual participant's SSRI/SNRI for tolerability issues.

Trial Locations (59)

333

Chang Gung Memorial Hospital, Taoyuan District

500

Changhua Christian Hospital, Changhua

1113

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

1137

Processus Kft, Budapest

1377

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

1900

Instituto de Neurociencias San Agustin, La Plata

2000

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

3200

Bugat Pal Korhaz, Gyöngyös

3570

Anima, Alken

5000

Fundacion Lennox, Córdoba

6100

Hacettepe University Medical Faculty, Ankara

7003

Mental Health Center - Rousse, Rousse

7530

Cape Town Clinical Research Centre, Cape Town

10002

National Taiwan University Hospital, Taipei

11217

Taipei Veterans General Hospital, Taipei

12209

Medizinisches Versorgungszentrum LiO GmbH, Berlin

13187

Praxis Dr. med. Kirsten Hahn, Berlin

16000

Medical Services Prague S R O, Prague

16761

Oberhavel Kliniken GmbH, Hennigsdorf

18600

Institut Neuropsychiatricke pece, Prague

19053

Somni Bene GmbH, Schwerin

19055

Klinische Forschung Schwerin GmbH, Schwerin

20253

Klinische Forschung Hamburg, Hamburg

26504

University General Hospital of Rio Patras, Pátrai

30990

Hospital Raja Permaisuri Bainun, Ipoh

31200

A Shine S R O, Pilsen

34736

Erenkoy Mental Health Hospital, Istanbul

43400

Hospital Pengajar Universiti Putra Malaysia, Serdang

44287

Klinikum Dortmund gGmbH, Dortmund

50002

NeuropsychiatrieHK, s.r.o., Hradec Králové

55020

Liv Hospital, Samsun

57010

G Papanikolaou Hospital of Thessaloniki, Thessaloniki

59100

University Malaya Medical Centre, Kuala Lumpur

60200

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

61500

Psychiatricka ambulance, MUDr. Marta Holanova, Brno

70300

Hospital Tuanku Jaafar, Seremban

71305

Psychiatric Clinic 'Agios Charalampos', Heraklion

79104

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

85276

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

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

109 00

AD71 s.r.o., Prague

00270

Mederon LTD at ARTES, Helsinki

09111

Pharmakologisches Studienzentrum Chemnitz GmbH, Mittweida

H-9024

Petz Aladar Megyei Oktato Korhaz, Győr

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

87 100

Osrodek Badan Klinicznych CLINSANTE S C, Torun

0 042

Gert Bosch Pretoria South Africa, Pretoria

03722

Severance Hospital Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Janssen-Cilag Ltd.

INDUSTRY