A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
NCT07227454 · AVENUE · Janssen Research & Development, LLC
What it is testing
Summary
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
Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose
Measured over Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2)
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
Where
35 study sites
| Facility | City | Region | Country |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | United States |
| Peachford Hospital-Atlanta Behavioral Research | Atlanta | Georgia | United States |
| Endeavor Health Evanston Hospital | Evanston | Illinois | United States |
| Mayo Clinic | Rochester | Minnesota | United States |
| University of Cincinnati | Cincinnati | Ohio | United States |
| Bradley Hospital | East Providence | Rhode Island | United States |
| John S Dunn Behavioral Sciences Center at UTHealth Houston | Houston | Texas | United States |
| Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose | Criciúma | — | Brazil |
| Instituto Apice | Salvador | — | Brazil |
| Centro Integrado Facili | São Bernardo do Campo | — | Brazil |
| Instituto de Pesquisa Pensi Sandra Mutarelli Setubal | São Paulo | — | Brazil |
| Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo | São Paulo | — | Brazil |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | — | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | — | Hungary |
| Szegedi Tudomanyegyetem | Szeged | — | Hungary |
| Presidio Ospedaliero Santa Marta e Santa Venera | Acireale | — | Italy |
| Azienda Ospedaliera G. Brotzu | Cagliari | — | Italy |
| AOU Meyer | Florence | — | Italy |
| Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia | Foggia | — | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | — | Italy |
| Azienda Ospedaliero Universitaria di Sassari | Sassari | — | Italy |
| Spitalul Clinic de Urgenta pentru Copii Cluj Napoca | Cluj-Napoca | — | Romania |
| Hosp Univ Vall D Hebron | Barcelona | — | Spain |
| Hosp. Clinic de Barcelona | Barcelona | — | Spain |
| Hosp. Sant Joan de Deu | Esplugues de Llobregat | — | Spain |
| Fundacio Althaia Xarxa Assistencial Universitaria de Manresa | Manresa | — | Spain |
| Hosp. Univ. Central de Asturias | Oviedo | — | Spain |
| Clinica Univ. de Navarra | Pamplona | — | Spain |
| Hosp.Univ.Parc Tauli | Sabadell | — | Spain |
| Mackay Memorial Hospital Tamsui Branch | New Taipei City | — | Taiwan |
| National Taiwan University Hospital | Taipei | — | Taiwan |
| Taipei Medical University Hospital | Taipei | — | Taiwan |
| Taipei Veterans General Hospital | Taipei | — | Taiwan |
| Tri-Service General Hospital | Taipei | — | Taiwan |
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.
NCT07227454 on ClinicalTrials.gov →
Last updated in the registry 2026-07-31. Registry records change; this page reflects the data build of 2026-08-25.
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