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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07227454
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Jan 8, 2026
Status verified
Jun 2026
Primary completion
Apr 9, 2031
Completion
Sep 15, 2031

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Peachford Hospital-Atlanta Behavioral ResearchAtlantaGeorgia30338-
University of CincinnatiCincinnatiOhio45219-
Bradley HospitalEast ProvidenceRhode Island02915-

Find similar trials in Birmingham, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Alabama at Birmingham· Birmingham, ALPeachford Hospital-Atlanta Behavioral Research· Atlanta, GAUniversity of Cincinnati· Cincinnati, OHBradley Hospital· East Providence, RI

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