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CompletedPhase 4Results posted

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.

Closed to entry
Status
Not accepting participants
Phase 4
Phase
183
Target enrolment
59
Study sites
Outside the US

What it is testing

Summary

The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).

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

18 Years to 74 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Completed the maintenance phase (Week 32) of Study 54135419TRD3013 (NCT04338321) and had esketamine nasal spray in combination with continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) administered through Week 30 (every 2 week dosing) or Week 31 (once weekly dosing) of Study 54135419TRD3013, and continues to be willing to be treated with esketamine nasal spray * Must, in the opinion of the investigator, be benefiting from continuation of esketamine nasal spray in combination with their current SSRI/SNRI based on efficacy and tolerability assessed on Day 1 of this study * Must be medically stable based on the investigator's judgment * A woman of childbearing potential must have a negative urine pregnancy test on Day 1 * Male participants who are sexually active with a woman of childbearing potential must agree to the following during the intervention period and for at least 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (that is, esketamine nasal spray), must fulfill the following criteria: must be practicing a highly effective method of contraception with his female partner, must use a condom if his partner is pregnant, and must agree not to donate sperm Exclusion Criteria: * Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments * Completed Study 54135419TRD3013 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant * Has developed during participation in Study 54135419TRD3013 any of the following cardiovascular-related conditions where an increase in blood pressure or intracranial pressure poses a serious risk: cerebrovascular disease following stroke or transient ischemic attack, aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), intracerebral hemorrhage, coronary artery disease following myocardial infarction, unstable angina, or revascularization procedure (example, coronary angioplasty or bypass graft surgery), uncontrolled brady- or tachyarrhythmias that lead to hemodynamic instability, hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation or heart failure (New York Heart Association \[NYHA\] Class III-IV) of any etiology * Significant pulmonary insufficiency, including chronic obstructive pulmonary disease * 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 Day 1, per the investigator's clinical judgment; or based on the Columbia-suicide severity rating scale (C-SSRS) performed at Week 32 visit of Study 54135419TRD3013, 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 * Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention

Where

59 study sites

FacilityCityRegionCountry
FunDaMosBuenos AiresArgentina
CEN Consultorios Especializados en NeurocienciasCórdobaArgentina
Fundacion LennoxCórdobaArgentina
Instituto Medico DAMICCórdobaArgentina
Sanatorio Prof Leon S Morra S ACórdobaArgentina
Instituto de Neurociencias San AgustinLa PlataArgentina
C I A P Centro de investigacion y Asistencia en PsiquiatriaRosarioArgentina
AnimaAlkenBelgium
Mental Health Center - RousseRousseBulgaria
Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti NaumSofiaBulgaria
Centre for Mental Health Prof.N.Shipkovenski EOODSofiaBulgaria
Psychiatricka ambulance Saint Anne s.r.o.BrnoCzechia
Psychiatricka ambulance, MUDr. Marta HolanovaBrnoCzechia
NeuropsychiatrieHK, s.r.o.Hradec KrálovéCzechia
A Shine S R OPilsenCzechia
AD71 s.r.o.PragueCzechia
Medical Services Prague S R OPragueCzechia
Institut Neuropsychiatricke pecePragueCzechia
Mederon LTD at ARTESHelsinkiFinland
Medizinisches Versorgungszentrum LiO GmbHBerlinGermany
Praxis Dr. med. Kirsten HahnBerlinGermany
Klinikum Dortmund gGmbHDortmundGermany
Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit PoliklinikFreiburg im BreisgauGermany
Klinische Forschung HamburgHamburgGermany
Oberhavel Kliniken GmbHHennigsdorfGermany
Pharmakologisches Studienzentrum Chemnitz GmbHMittweidaGermany
Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und PsychosomatikPfaffenhofenGermany
Somni Bene GmbHSchwerinGermany
Klinische Forschung Schwerin GmbHSchwerinGermany
Psychiatric Clinic 'Agios Charalampos'HeraklionGreece
University General Hospital of Rio PatrasPátraiGreece
G Papanikolaou Hospital of ThessalonikiThessalonikiGreece
Processus KftBudapestHungary
Bugat Pal KorhazGyöngyösHungary
Petz Aladar Megyei Oktato KorhazGyőrHungary
Hospital Raja Permaisuri BainunIpohMalaysia
University Malaya Medical CentreKuala LumpurMalaysia
Hospital Pengajar Universiti Putra MalaysiaSerdangMalaysia
Hospital Tuanku JaafarSerembanMalaysia
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna LazarczykBialystokPoland
Osrodek Badan Klinicznych CLINSANTE S CBydgoszczPoland
Uniwersyteckie Centrum KliniczneGdanskPoland
Centrum Badan Klinicznych PI House sp z o oGdanskPoland
Centrum Medyczne Care Clinic KatowiceKatowicePoland
Niepubliczny Zaklad Opieki Psychiatrycznej MENTISLesznoPoland
Specjalistyczny Psychiatryczny Zespol Opieki Zdrowotnej w Lodzi Szpital im. J. BabinskiegoLodzPoland
SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i PsychotycznychLodzPoland
Osrodek Badan Klinicznych CLINSANTE S CTorunPoland
Cape Town Clinical Research CentreCape TownSouth Africa
Gert Bosch Pretoria South AfricaPretoriaSouth Africa
Severance Hospital Yonsei University Health SystemSeoulSouth Korea
Samsung Medical CenterSeoulSouth Korea
Changhua Christian HospitalChanghuaTaiwan
National Taiwan University HospitalTaipeiTaiwan
Taipei Veterans General HospitalTaipeiTaiwan
Chang Gung Memorial HospitalTaoyuanTaiwan
Hacettepe University Medical FacultyAnkaraTurkey (Türkiye)
Erenkoy Mental Health HospitalIstanbulTurkey (Türkiye)
Liv HospitalSamsunTurkey (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