NCT04476446 is a Phase 3 clinical trial of Esketamine in Depression, sponsored by Janssen-Cilag, S.A..

Who is sponsoring NCT04476446?

NCT04476446 is sponsored by Janssen-Cilag, S.A..

What drugs are being tested in NCT04476446?

Interventions in NCT04476446: Esketamine.

What condition does NCT04476446 study?

NCT04476446 studies Depression.

Is NCT04476446 still recruiting?

NCT04476446 is currently completed. Last updated 14 September 2023.

Last reviewed 2023-09-14 · How we verify

NCT04476446

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives

Completed Phase 3 Last updated 14 September 2023

What this trial tests

Phase 3 trial testing Esketamine in Depression in 41 participants. Completed in 16 June 2023.

Timeline

8 September 2020

Primary endpoint
16 June 2023

16 June 2023

Quick facts

Lead sponsor	Janssen-Cilag, S.A.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	8 September 2020
Primary completion	16 June 2023
Estimated completion	16 June 2023
Sites	8 locations across Mexico

Drugs / interventions tested

Esketamine (ESKETAMINE) — full drug profile →

Conditions studied

Depression — all drugs for Depression →

Sponsor

Janssen-Cilag, S.A. — full company profile →

Who can join

Adults 18 to 80, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with Treatment-Resistant Depression (TRD).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status.
Henter ID, Park LT, Zarate CA. · · 2021 · cited 104× · PMID 33904154 · DOI 10.1007/s40263-021-00816-x
Molecular Mechanisms of Emerging Antidepressant Strategies: From Ketamine to Neuromodulation.
Kowalczyk M, Aebisher D, Szpara J, Czech S, et al · · 2025 · PMID 41516220 · DOI 10.3390/ijms27010344

Verify or expand the search:

Other trials of Esketamine

Trials testing the same drug.

NCT07315074 — Effect of Esketamine on Postoperative Sleep in Postmenopausal Women · NA · not yet recruiting
NCT07374458 — Effects of Esketamine and Bilateral Lower Limb Elevation on Hemodynamic Stability During Induction of General Anesthesia · NA · not yet recruiting
NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder · Phase 3 · recruiting
NCT06788444 — Efficacy of Esketamine for Patients With Irritable Bowel Syndrome · NA · recruiting
NCT07179913 — The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoper · Phase 4 · not yet recruiting

Other recruiting trials for Depression

Currently open trials in the same condition.

NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT06906939 — A Randomized Pilot rTMS Trial for Knee Arthritis Pain and Depression · EARLY_PHASE1 · recruiting
NCT07517549 — Sexual Health Education During Pregnancy · NA · recruiting
NCT06408246 — ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression · Phase 2 · recruiting
NCT07449676 — Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression · NA · recruiting

Other Janssen-Cilag, S.A. trials

Trials by the same sponsor.

NCT03207282 — Treatment Resistant Depression in America Latina · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04476446 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen-Cilag, S.A.
Last refreshed: 14 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04476446.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing