Back to Trials
NCT07227454PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

1/8/2026

Completion Date

9/15/2031

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.

Eligibility Criteria

Age Range: 12 years to 17 years

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

Interventions

DRUG

Esketamine

DRUG

Midazolam

OTHER

Oral Placebo

OTHER

Intranasal Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Depressive Disorder, Major

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010

United States

Peachford Hospital-Atlanta Behavioral Research

Atlanta, Georgia 30338

United States

Endeavor Health Evanston Hospital

Evanston, Illinois 60201

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Bradley Hospital

East Providence, Rhode Island 02915

United States

John S Dunn Behavioral Sciences Center at UTHealth Houston

Houston, Texas 77021

United States

Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

Criciúma, 88811 000

Brazil

Instituto Apice

Salvador, 40170 108

Brazil

Centro Integrado Facili

São Bernardo do Campo, 09726 150

Brazil

Instituto de Pesquisa Pensi Sandra Mutarelli Setubal

São Paulo, 01 227 200

Brazil

Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo

São Paulo, 05403 010

Brazil

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4031

Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, 9023

Hungary

Szegedi Tudomanyegyetem

Szeged, 6720

Hungary

Presidio Ospedaliero Santa Marta e Santa Venera

Acireale, 95024

Italy

Azienda Ospedaliera G. Brotzu

Cagliari, 09134

Italy

AOU Meyer

Florence, 50134

Italy

Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia

Foggia, 71122

Italy

Azienda Ospedaliera Universitaria Federico II

Naples, 80131

Italy

Azienda Ospedaliero Universitaria di Sassari

Sassari, 07100

Italy

Spitalul Clinic de Urgenta pentru Copii Cluj Napoca

Cluj-Napoca, 400658

Romania

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Sant Joan de Deu

Esplugues de Llobregat, 08950

Spain

Fundacio Althaia Xarxa Assistencial Universitaria de Manresa

Manresa, 08243

Spain

Hosp. Univ. Central de Asturias

Oviedo, 33011

Spain

Clinica Univ. de Navarra

Pamplona, 31008

Spain

Hosp.Univ.Parc Tauli

Sabadell, 08208

Spain

Mackay Memorial Hospital Tamsui Branch

New Taipei City, 251

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Medical University Hospital

Taipei, 110

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Tri-Service General Hospital

Taipei, 114

Taiwan