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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT07227454

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Esketamine (Drug)
    Esketamine will be administered as intranasal solution.
  • Midazolam (Drug)
    Midazolam will be administered as oral solution.
  • Oral Placebo (Other)
    Placebo will be administered as oral solution.
  • Intranasal Placebo (Other)
    Intranasal placebo will be administered as nasal solution.

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

Conditions

Depressive Disorder, Major

Locations

  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Children's National Medical Center — Washington D.C., District of Columbia, United States
  • Peachford Hospital-Atlanta Behavioral Research — Atlanta, Georgia, United States
  • Endeavor Health Evanston Hospital — Evanston, Illinois, United States
  • Johns Hopkins University — Baltimore, Maryland, United States
  • Boston Childrens Hospital — Boston, Massachusetts, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • University of Cincinnati — Cincinnati, Ohio, United States
  • Bradley Hospital — East Providence, Rhode Island, United States
  • John S Dunn Behavioral Sciences Center at UTHealth Houston — Houston, Texas, United States
  • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose — Criciúma, Brazil
  • Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes — Natal, Brazil
  • Instituto Apice — Salvador, Brazil
  • Centro Integrado Facili — São Bernardo do Campo, Brazil
  • Instituto de Pesquisa Pensi Sandra Mutarelli Setubal — São Paulo, Brazil
  • Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo, Brazil
  • Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
  • Petz Aladar Megyei Oktato Korhaz — Győr, Hungary
  • Szegedi Tudomanyegyetem — Szeged, Hungary
  • Presidio Ospedaliero Santa Marta e Santa Venera — Acireale, Italy
  • Azienda Ospedaliera G. Brotzu — Cagliari, Italy
  • AOU Meyer — Florence, Italy
  • Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia — Foggia, Italy
  • G.Gaslini Institute — Genova, Italy
  • Ospedale di Merano — Merano, Italy
  • Azienda Ospedaliera Universitaria Federico II — Naples, Italy
  • Azienda Ospedaliero Universitaria di Sassari — Sassari, Italy
  • Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia — Bucharest, Romania
  • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca — Cluj-Napoca, Romania
  • Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda — Sibiu, Romania
  • Spitalul Clinic de Urgenta pentru Copii 'Louis Turcanu' Timisoara — Timișoara, Romania
  • Hosp Univ Vall D Hebron — Barcelona, Spain
  • Hosp. Clinic de Barcelona — Barcelona, Spain
  • Hosp. Sant Joan de Deu — Esplugues de Llobregat, Spain
  • Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
  • Fundacio Althaia Xarxa Assistencial Universitaria de Manresa — Manresa, Spain
  • Hosp. Univ. Central de Asturias — Oviedo, Spain
  • Clinica Univ. de Navarra — Pamplona, Spain
  • Hosp.Univ.Parc Tauli — Sabadell, Spain
  • Mackay Memorial Hospital Tamsui Branch — New Taipei City, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Taipei Medical University Hospital — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Tri-Service General Hospital — Taipei, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record