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RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder

NCT07227454 · AVENUE · Janssen Research & Development, LLC

Recruiting
Status
Accepting participants
Phase 3
Phase
258
Target enrolment
35
Study sites
8 US states

What it is testing

Summary

The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.

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

12 Years to 17 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID) * Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal to \[\>=\] 4) at both screening and baseline (predose) visits * Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose) * In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality * Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening Exclusion Criteria: * Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder * Participant currently meets DSM-5 criteria for borderline personality disorder * Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis * Participant has a history of seizure disorder * Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients

Where

35 study sites

FacilityCityRegionCountry
University of Alabama at BirminghamBirminghamAlabamaUnited States
Children's National Medical CenterWashington D.C.District of ColumbiaUnited States
Peachford Hospital-Atlanta Behavioral ResearchAtlantaGeorgiaUnited States
Endeavor Health Evanston HospitalEvanstonIllinoisUnited States
Mayo ClinicRochesterMinnesotaUnited States
University of CincinnatiCincinnatiOhioUnited States
Bradley HospitalEast ProvidenceRhode IslandUnited States
John S Dunn Behavioral Sciences Center at UTHealth HoustonHoustonTexasUnited States
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao JoseCriciúmaBrazil
Instituto ApiceSalvadorBrazil
Centro Integrado FaciliSão Bernardo do CampoBrazil
Instituto de Pesquisa Pensi Sandra Mutarelli SetubalSão PauloBrazil
Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao PauloSão PauloBrazil
Debreceni Egyetem Klinikai KozpontDebrecenHungary
Petz Aladar Megyei Oktato KorhazGyőrHungary
Szegedi TudomanyegyetemSzegedHungary
Presidio Ospedaliero Santa Marta e Santa VeneraAcirealeItaly
Azienda Ospedaliera G. BrotzuCagliariItaly
AOU MeyerFlorenceItaly
Azienda Ospedaliera Universitaria Policlinico Riuniti di FoggiaFoggiaItaly
Azienda Ospedaliera Universitaria Federico IINaplesItaly
Azienda Ospedaliero Universitaria di SassariSassariItaly
Spitalul Clinic de Urgenta pentru Copii Cluj NapocaCluj-NapocaRomania
Hosp Univ Vall D HebronBarcelonaSpain
Hosp. Clinic de BarcelonaBarcelonaSpain
Hosp. Sant Joan de DeuEsplugues de LlobregatSpain
Fundacio Althaia Xarxa Assistencial Universitaria de ManresaManresaSpain
Hosp. Univ. Central de AsturiasOviedoSpain
Clinica Univ. de NavarraPamplonaSpain
Hosp.Univ.Parc TauliSabadellSpain
Mackay Memorial Hospital Tamsui BranchNew Taipei CityTaiwan
National Taiwan University HospitalTaipeiTaiwan
Taipei Medical University HospitalTaipeiTaiwan
Taipei Veterans General HospitalTaipeiTaiwan
Tri-Service General HospitalTaipeiTaiwan

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.

Related

Where this trial sits