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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.

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

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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

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

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