A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
NCT04829318 · ESCAPE-LTE · Janssen-Cilag Ltd.
What it is testing
Summary
Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.
What counts as success
Primary outcome measures
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Incidence Rate of Treatment-emergent Adverse Events (TEAEs)
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Incidence Rate of Treatment-emergent Serious Adverse Events (TESAEs)
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Percentage of of Participants With TEAEs Leading to Death
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Incidence Rate of TEAEs Leading to Death
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Percentage of Participants With Treatment-emergent AEs of Special Interest (AESIs)
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Incidence Rate of Treatment-emergent AEs of Special Interest (AESIs)
Measured over From Day 1 of study 54135419TRD4010 up to 30 days after last dose of study drug at Week 104 (up to Week 108)
Number of Participants With Suicidal Ideation and Behavior in Study 54135419TRD4010 as Assessed by Columbia-suicide Severity Rating Scale (C-SSRS) Score
Measured over Baseline (Day 1 of Study 54135419TRD3013) up to Week 104 of study 54135419TRD4010 (up to Week 136)
A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.
Who can take part
Eligibility, as published
Where
59 study sites
| Facility | City | Region | Country |
|---|---|---|---|
| FunDaMos | Buenos Aires | — | Argentina |
| CEN Consultorios Especializados en Neurociencias | Córdoba | — | Argentina |
| Fundacion Lennox | Córdoba | — | Argentina |
| Instituto Medico DAMIC | Córdoba | — | Argentina |
| Sanatorio Prof Leon S Morra S A | Córdoba | — | Argentina |
| Instituto de Neurociencias San Agustin | La Plata | — | Argentina |
| C I A P Centro de investigacion y Asistencia en Psiquiatria | Rosario | — | Argentina |
| Anima | Alken | — | Belgium |
| Mental Health Center - Rousse | Rousse | — | Bulgaria |
| Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum | Sofia | — | Bulgaria |
| Centre for Mental Health Prof.N.Shipkovenski EOOD | Sofia | — | Bulgaria |
| Psychiatricka ambulance Saint Anne s.r.o. | Brno | — | Czechia |
| Psychiatricka ambulance, MUDr. Marta Holanova | Brno | — | Czechia |
| NeuropsychiatrieHK, s.r.o. | Hradec Králové | — | Czechia |
| A Shine S R O | Pilsen | — | Czechia |
| AD71 s.r.o. | Prague | — | Czechia |
| Medical Services Prague S R O | Prague | — | Czechia |
| Institut Neuropsychiatricke pece | Prague | — | Czechia |
| Mederon LTD at ARTES | Helsinki | — | Finland |
| Medizinisches Versorgungszentrum LiO GmbH | Berlin | — | Germany |
| Praxis Dr. med. Kirsten Hahn | Berlin | — | Germany |
| Klinikum Dortmund gGmbH | Dortmund | — | Germany |
| Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik | Freiburg im Breisgau | — | Germany |
| Klinische Forschung Hamburg | Hamburg | — | Germany |
| Oberhavel Kliniken GmbH | Hennigsdorf | — | Germany |
| Pharmakologisches Studienzentrum Chemnitz GmbH | Mittweida | — | Germany |
| Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik | Pfaffenhofen | — | Germany |
| Somni Bene GmbH | Schwerin | — | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | — | Germany |
| Psychiatric Clinic 'Agios Charalampos' | Heraklion | — | Greece |
| University General Hospital of Rio Patras | Pátrai | — | Greece |
| G Papanikolaou Hospital of Thessaloniki | Thessaloniki | — | Greece |
| Processus Kft | Budapest | — | Hungary |
| Bugat Pal Korhaz | Gyöngyös | — | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | — | Hungary |
| Hospital Raja Permaisuri Bainun | Ipoh | — | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | — | Malaysia |
| Hospital Pengajar Universiti Putra Malaysia | Serdang | — | Malaysia |
| Hospital Tuanku Jaafar | Seremban | — | Malaysia |
| Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk | Bialystok | — | Poland |
| Osrodek Badan Klinicznych CLINSANTE S C | Bydgoszcz | — | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | — | Poland |
| Centrum Badan Klinicznych PI House sp z o o | Gdansk | — | Poland |
| Centrum Medyczne Care Clinic Katowice | Katowice | — | Poland |
| Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS | Leszno | — | Poland |
| Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. Babinskiego | Lodz | — | Poland |
| SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych | Lodz | — | Poland |
| Osrodek Badan Klinicznych CLINSANTE S C | Torun | — | Poland |
| Cape Town Clinical Research Centre | Cape Town | — | South Africa |
| Gert Bosch Pretoria South Africa | Pretoria | — | South Africa |
| Severance Hospital Yonsei University Health System | Seoul | — | South Korea |
| Samsung Medical Center | Seoul | — | South Korea |
| Changhua Christian Hospital | Changhua | — | Taiwan |
| National Taiwan University Hospital | Taipei | — | Taiwan |
| Taipei Veterans General Hospital | Taipei | — | Taiwan |
| Chang Gung Memorial Hospital | Taoyuan | — | Taiwan |
| Hacettepe University Medical Faculty | Ankara | — | Turkey (Türkiye) |
| Erenkoy Mental Health Hospital | Istanbul | — | Turkey (Türkiye) |
| Liv Hospital | Samsun | — | Turkey (Türkiye) |
On the registry
Contact the trial directly
This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.
Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.
NCT04829318 on ClinicalTrials.gov →
Last updated in the registry 2025-09-18. Registry records change; this page reflects the data build of 2026-08-25.
Related
Where this trial sits
Substance
Indication