Recruiting
Phase 3

JNJ-54135419

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07227454

Conditions

Depressive Disorder, Major

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Esketamine

Midazolam

Oral Placebo

Intranasal Placebo

Study Details

Brief 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.

Conditions

Depressive Disorder, Major

Study ID

NCT07227454

Start date

Jan 8, 2026

Status verified date

Aug, 2026

Completion date

Sep 15, 2031

Anticipated

Primary completion date

Apr 9, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intranasal Esketamine + Oral Placebo

Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.

placebo comparator: Intranasal Placebo + Oral Midazolam

Participants will receive oral midazolam (0.0625 milligrams per kilograms \[mg/kg\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.

Interventions

Esketamine

Esketamine will be administered as intranasal solution.

Midazolam

Midazolam will be administered as oral solution.

Oral Placebo

Placebo will be administered as oral solution.

Intranasal Placebo

Intranasal placebo will be administered as nasal solution.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Peachford Hospital-Atlanta Behavioral Research

Recruiting

Atlanta, Georgia, United States, 30338

Endeavor Health Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Boston Childrens Hospital

Recruiting

Boston, Massachusetts, United States, 02445

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Bradley Hospital

Recruiting

East Providence, Rhode Island, United States, 02915

John S Dunn Behavioral Sciences Center at UTHealth Houston

Recruiting

Houston, Texas, United States, 77021

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.