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

NCT ID NCT04829318

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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