Recruiting

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

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.

ClinicalTrials.gov IDNCT07227454

PhasePHASE3

Enrollment258

SponsorJanssen Research & Development, LLC

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Depressive Disorder, Major

About this study

Interventions

Drug: Esketamine — Esketamine will be administered as intranasal solution.
Drug: Midazolam — Midazolam will be administered as oral solution.
Other: Oral Placebo — Placebo will be administered as oral solution.
Other: Intranasal Placebo — Intranasal placebo will be administered as nasal solution.

Primary outcomes

Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose (Baseline (pre-dose on Day 1) and 24 hours post first dose (i.e., Day 2))

Eligibility information

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

Study 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
Johns Hopkins University, Baltimore, Maryland 21287 United States
Boston Childrens Hospital, Boston, Massachusetts 02445 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

Showing 10 of 44 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.