Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Esketamine nasal Spray's Long-Term safety under the microscope

NCT ID NCT04829318

Disease control Sponsor: Janssen-Cilag Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of esketamine nasal spray (a fast-acting antidepressant) when used together with standard antidepressants in 183 people with treatment-resistant depression. Participants had already completed 32 weeks of esketamine treatment and continued for up to 104 more weeks. The main goal was to track side effects, including serious events and those of special interest like sedation or suicidal thoughts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Esketamine nasal spray
What this could lead to
If successful, this could show that long-term esketamine is safe and tolerable for people with hard-to-treat depression, supporting its continued use.
What could go wrong
This is a safety extension study, not designed to prove effectiveness. Side effects like sedation, dissociation, or abuse potential are possible. Results may not apply to all depression patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

183 people

The number who actually took part.

Started

Apr 2021

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Depressive disorder, major are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major

Contacts and locations

Locations

  • A Shine S R O

    Pilsen, 31200, Czechia

  • AD71 s.r.o.

    Prague, 109 00, Czechia

  • Anima

    Alken, 3570, Belgium

  • Bugat Pal Korhaz

    Gyöngyös, 3200, Hungary

  • C I A P Centro de investigacion y Asistencia en Psiquiatria

    Rosario, 2000, Argentina

  • CEN Consultorios Especializados en Neurociencias

    Córdoba, 5000FJF, Argentina

  • Cape Town Clinical Research Centre

    Cape Town, 7530, South Africa

  • Centre for Mental Health Prof.N.Shipkovenski EOOD

    Sofia, 1377, Bulgaria

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546, Poland

  • Centrum Medyczne Care Clinic Katowice

    Katowice, 40-568, Poland

  • Chang Gung Memorial Hospital

    Taoyuan, 333, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Danuvius Klinik Pfaffenhofen Fachklinik für Psychiatrie, Psychotherapie und Psychosomatik

    Pfaffenhofen, 85276, Germany

  • Erenkoy Mental Health Hospital

    Istanbul, 34736, Turkey (Türkiye)

  • FunDaMos

    Buenos Aires, C1405BOA, Argentina

  • Fundacion Lennox

    Córdoba, 5000, Argentina

  • G Papanikolaou Hospital of Thessaloniki

    Thessaloniki, 57010, Greece

  • Gert Bosch Pretoria South Africa

    Pretoria, 0 042, South Africa

  • Hacettepe University Medical Faculty

    Ankara, 6100, Turkey (Türkiye)

  • Hospital Pengajar Universiti Putra Malaysia

    Serdang, 43400, Malaysia

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30990, Malaysia

  • Hospital Tuanku Jaafar

    Seremban, 70300, Malaysia

  • Institut Neuropsychiatricke pece

    Prague, 18600, Czechia

  • Instituto Medico DAMIC

    Córdoba, X5003DCE, Argentina

  • Instituto de Neurociencias San Agustin

    La Plata, 1900, Argentina

  • Klinikum Dortmund gGmbH

    Dortmund, 44287, Germany

  • Klinische Forschung Hamburg

    Hamburg, 20253, Germany

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055, Germany

  • Liv Hospital

    Samsun, 55020, Turkey (Türkiye)

  • Mederon LTD at ARTES

    Helsinki, 00270, Finland

  • Medical Services Prague S R O

    Prague, 16000, Czechia

  • Medizinisches Versorgungszentrum LiO GmbH

    Berlin, 12209, Germany

  • Mental Health Center - Rousse

    Rousse, 7003, Bulgaria

  • Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

    Bialystok, 15-404, Poland

  • Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

    Sofia, 1113, Bulgaria

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • NeuropsychiatrieHK, s.r.o.

    Hradec Králové, 50002, Czechia

  • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

    Leszno, 64-100, Poland

  • Oberhavel Kliniken GmbH

    Hennigsdorf, 16761, Germany

  • Osrodek Badan Klinicznych CLINSANTE S C

    Bydgoszcz, 85 794, Poland

  • Osrodek Badan Klinicznych CLINSANTE S C

    Torun, 87 100, Poland

  • Petz Aladar Megyei Oktato Korhaz

    Győr, H-9024, Hungary

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Mittweida, 09111, Germany

  • Praxis Dr. med. Kirsten Hahn

    Berlin, 13187, Germany

  • Processus Kft

    Budapest, 1137, Hungary

  • Psychiatric Clinic 'Agios Charalampos'

    Heraklion, 71305, Greece

  • Psychiatricka ambulance Saint Anne s.r.o.

    Brno, 60200, Czechia

  • Psychiatricka ambulance, MUDr. Marta Holanova

    Brno, 61500, Czechia

  • SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych

    Lodz, 92-216, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sanatorio Prof Leon S Morra S A

    Córdoba, X5009BIN, Argentina

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Somni Bene GmbH

    Schwerin, 19053, Germany

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

    Lodz, 91-229, Poland

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • University General Hospital of Rio Patras

    Pátrai, 26504, Greece

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • Universitätsklinikum Freiburg - Abteilung für Psychiatrie u. Psychotherapie mit Poliklinik

    Freiburg im Breisgau, 79104, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.