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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
44
Study sites
10 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

44 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
Johns Hopkins UniversityBaltimoreMarylandUnited States
Boston Childrens HospitalBostonMassachusettsUnited 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 JoseCriciúma-Brazil
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre LopesNatal-Brazil
Instituto ApiceSalvador-Brazil
Centro Integrado FaciliSão Bernardo do Campo-Brazil
Instituto de Pesquisa Pensi Sandra Mutarelli SetubalSão Paulo-Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USPSão Paulo-Brazil
Debreceni Egyetem Klinikai KozpontDebrecen-Hungary
Petz Aladar Megyei Oktato KorhazGyőr-Hungary
Szegedi TudomanyegyetemSzeged-Hungary
Presidio Ospedaliero Santa Marta e Santa VeneraAcireale-Italy
Azienda Ospedaliera G. BrotzuCagliari-Italy
AOU MeyerFlorence-Italy
Azienda Ospedaliera Universitaria Policlinico Riuniti di FoggiaFoggia-Italy
G.Gaslini InstituteGenova-Italy
Ospedale di MeranoMerano-Italy
Azienda Ospedaliera Universitaria Federico IINaples-Italy
Azienda Ospedaliero Universitaria di SassariSassari-Italy
Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest-Romania
Spitalul Clinic de Urgenta pentru Copii Cluj NapocaCluj-Napoca-Romania
Spitalul Clinic De Psihiatrie Doctor Gheorghe PredaSibiu-Romania
Spitalul Clinic de Urgenta pentru Copii 'Louis Turcanu' TimisoaraTimișoara-Romania
Hosp Univ Vall D HebronBarcelona-Spain
Hosp. Clinic de BarcelonaBarcelona-Spain
Hosp. Sant Joan de DeuEsplugues de Llobregat-Spain
Hosp. Gral. Univ. Gregorio MaranonMadrid-Spain
Fundacio Althaia Xarxa Assistencial Universitaria de ManresaManresa-Spain
Hosp. Univ. Central de AsturiasOviedo-Spain
Clinica Univ. de NavarraPamplona-Spain
Hosp.Univ.Parc TauliSabadell-Spain
Mackay Memorial Hospital Tamsui BranchNew Taipei City-Taiwan
National Taiwan University HospitalTaipei-Taiwan
Taipei Medical University HospitalTaipei-Taiwan
Taipei Veterans General HospitalTaipei-Taiwan
Tri-Service General HospitalTaipei-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. The registry also holds the most current version of everything above.

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 2026-09-25. Registry records change; this page reflects the data build of 2026-10-06.

Related

Where this trial sits