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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT07227454

Run by

Janssen Research & Development, LLC

People needed

258

Starts

2026-01-08

Expected to finish

2031-09-15

Last updated by the study team

2026-07-31

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Peachford Hospital-Atlanta Behavioral Research — Atlanta, Georgia, United States (enrolling)
• Endeavor Health Evanston Hospital — Evanston, Illinois, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• Bradley Hospital — East Providence, Rhode Island, United States (enrolling)
• John S Dunn Behavioral Sciences Center at UTHealth Houston — Houston, Texas, United States (enrolling)
• Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose — Criciúma, Brazil (enrolling)
• Instituto Apice — Salvador, Brazil (enrolling)
• Centro Integrado Facili — São Bernardo do Campo, Brazil (enrolling)
• Instituto de Pesquisa Pensi Sandra Mutarelli Setubal — São Paulo, Brazil (enrolling)
• Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo — São Paulo, Brazil (enrolling)
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary (enrolling)
• Petz Aladar Megyei Oktato Korhaz — Győr, Hungary (enrolling)
• Szegedi Tudomanyegyetem — Szeged, Hungary (enrolling)
• Presidio Ospedaliero Santa Marta e Santa Venera — Acireale, Italy (enrolling)
• Azienda Ospedaliera G. Brotzu — Cagliari, Italy (enrolling)
• AOU Meyer — Florence, Italy (enrolling)
• Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia — Foggia, Italy (enrolling)
• Azienda Ospedaliera Universitaria Federico II — Naples, Italy (enrolling)
• Azienda Ospedaliero Universitaria di Sassari — Sassari, Italy (enrolling)
• Spitalul Clinic de Urgenta pentru Copii Cluj Napoca — Cluj-Napoca, Romania (enrolling)
• Hosp Univ Vall D Hebron — Barcelona, Spain (enrolling)
• Hosp. Clinic de Barcelona — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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