Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
NCT03185819 · 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 Children's Depression Rating Scale-Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Day 2)
Measured over Baseline (predose on Day 1) and 24 hours post first dose on Day 1 (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
51 study sites
| Facility | City | Region | Country |
|---|---|---|---|
| Institute of Living/ Hartford Hospital | Hartford | Connecticut | United States |
| Yale University | New Haven | Connecticut | United States |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | United States |
| Rush University Medical Center | Chicago | Illinois | United States |
| Neuroscience Research Institute | Winfield | Illinois | United States |
| Beacon Medical Group Clinical Research | South Bend | Indiana | United States |
| University of Iowa, Carver College of Medicine | Iowa City | Iowa | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | United States |
| CBH Health | Gaithersburg | Maryland | United States |
| State University of New York at Buffalo | Buffalo | New York | United States |
| University North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | United States |
| University of Cincinnati Hospital | Cincinnati | Ohio | United States |
| University Hospital of Cleveland | Cleveland | Ohio | United States |
| Ohio State University | Columbus | Ohio | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | United States |
| Hopital Erasme | Brussels | — | Belgium |
| Trial Tech Tecnologia em Pesquisas com Medicamentos | Curitiba | — | Brazil |
| Hospital Universitario Professor Edgar Santos | Salvador | — | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | — | Brazil |
| Hospital São Sebastião | Turvo | — | Brazil |
| Mental Health Center - Rousse | Rousse | — | Bulgaria |
| Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD | Varna | — | Bulgaria |
| Hospices Civils de Lyon HCL | Bron | — | France |
| CHRU Lille - Hôpital Fontan 1 | Lille | — | France |
| CHU Nantes | Nantes | — | France |
| Hôpital Universitaire Pitié-Salpêtrière | Paris | — | France |
| Hopital Sainte Anne | Paris | — | France |
| Hôpital Robert Debré | Paris | — | France |
| Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es Szakambulancia | Budapest | — | Hungary |
| Szegedi Tudomanyegyetem | Szeged | — | Hungary |
| Azienda Ospedaliera G. Brotzu | Cagliari | — | Italy |
| OSP RIUNITI-DIP Donna- Bambino | Foggia | — | Italy |
| Ospedale di Merano | Merano | — | Italy |
| Azienda Ospedaliera Universitaria Policlinico G. Martino | Messina | — | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | — | Italy |
| IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione | Pavia | — | Italy |
| Irccs Burlo-Garofalo | Trieste | — | Italy |
| Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ | Krakow | — | Poland |
| Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego | Warsaw | — | Poland |
| Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy | Warsaw | — | Poland |
| Hosp Clinic de Barcelona | Barcelona | — | Spain |
| Hosp. Sant Joan de Deu | Esplugues de Llobregat | — | Spain |
| Hosp. Gral. Univ. Gregorio Maranon | Madrid | — | Spain |
| Hosp. Infantil Univ. Nino Jesus | Madrid | — | Spain |
| Hosp. Univ. Pta. de Hierro Majadahonda | Majadahonda | — | Spain |
| Hosp. Univ. Central de Asturias | Oviedo | — | Spain |
| Clinica Univ. de Navarra | Pamplona | — | Spain |
| Corporacio Sanitari Parc Tauli | Sabadell | — | Spain |
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.
NCT03185819 on ClinicalTrials.gov →
Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.
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