A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior
- Depressive Disorder, Major
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 258
- Started
- 8 January 2026
- Main results due
- 9 April 2031
- Study sites
- 44
- Registry updated
- 25 September 2026
Can you take part?
- Ages 12 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(44)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, United States
Recruiting
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia, United States
Recruiting
Endeavor Health Evanston Hospital
Evanston, Illinois, United States
Recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Recruiting
Boston Childrens Hospital
Boston, Massachusetts, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
Bradley Hospital
East Providence, Rhode Island, United States
Recruiting
John S Dunn Behavioral Sciences Center at UTHealth Houston
Houston, Texas, United States
Recruiting
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, Brazil
Recruiting
Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes
Natal, Brazil
Recruiting
Instituto Apice
Salvador, Brazil
Recruiting
Centro Integrado Facili
São Bernardo do Campo, Brazil
Recruiting
Instituto de Pesquisa Pensi Sandra Mutarelli Setubal
São Paulo, Brazil
Recruiting
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, Brazil
Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Recruiting
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary
Recruiting
Szegedi Tudomanyegyetem
Szeged, Hungary
Recruiting
Presidio Ospedaliero Santa Marta e Santa Venera
Acireale, Italy
Recruiting
Azienda Ospedaliera G. Brotzu
Cagliari, Italy
Recruiting
AOU Meyer
Florence, Italy
Recruiting
Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia
Foggia, Italy
Recruiting
G.Gaslini Institute
Genova, Italy
Recruiting
Ospedale di Merano
Merano, Italy
Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Recruiting
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy
Recruiting
Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia
Bucharest, Romania
Recruiting
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca
Cluj-Napoca, Romania
Recruiting
Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda
Sibiu, Romania
Recruiting
Spitalul Clinic de Urgenta pentru Copii 'Louis Turcanu' Timisoara
Timișoara, Romania
Recruiting
Hosp Univ Vall D Hebron
Barcelona, Spain
Recruiting
Hosp. Clinic de Barcelona
Barcelona, Spain
Recruiting
Hosp. Sant Joan de Deu
Esplugues de Llobregat, Spain
Recruiting
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Recruiting
Fundacio Althaia Xarxa Assistencial Universitaria de Manresa
Manresa, Spain
Recruiting
Hosp. Univ. Central de Asturias
Oviedo, Spain
Recruiting
Clinica Univ. de Navarra
Pamplona, Spain
Recruiting
Hosp.Univ.Parc Tauli
Sabadell, Spain
Recruiting
Mackay Memorial Hospital Tamsui Branch
New Taipei City, Taiwan
Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Recruiting
Taipei Medical University Hospital
Taipei, Taiwan
Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan
Recruiting
Tri-Service General Hospital
Taipei, Taiwan
Recruiting
Showing 44 of 44 sites. 44 of the 44 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07227454. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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