Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07227454 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
A Phase 3 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 258
- Enrollment target
- 2
- Study locations
NCT07227454: Recruiting Phase 3 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.
NCT07227454 is a Phase 3 study of Depressive Disorder, Major that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 258 participants, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07227454, a Phase 3 study of Depressive Disorder, Major, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 258 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The CDRS-R is a 17-item, clinician-reported outcome measure of children's depressive symptom severity. Out of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5 point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more severe depression. The CDRS-R total score was the sum of the 17-tems score and it ranged fr
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Esketamine
- OTHER Oral Placebo
- OTHER Intranasal Placebo
Study Locations (2)
Georgia
- Peachford Hospital-Atlanta Behavioral Research - Atlanta
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2026-01-08 |
| Est. Completion | 2031-09-15 |
| Phase | Phase 3 |
What NCT07227454 shows while recruiting
NCT07227454 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target.
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 4 interventions - of which Midazolam is the first listed.
NCT07227454 reports a single indexed study location in Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT07227454 about?
NCT07227454 is a clinical study titled "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 activitie...
What is the current status of trial NCT07227454?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 258 participants. The study started on 2026-01-08. Estimated completion is 2031-09-15.
What conditions does trial NCT07227454 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT07227454?
The interventions under investigation include: Midazolam (DRUG), Esketamine (DRUG), Oral Placebo (OTHER), Intranasal Placebo (OTHER).
Who is sponsoring clinical trial NCT07227454?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227454 being conducted?
This trial has 2 study locations across Georgia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depressive Disorder, Major
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07227454's enrollment target sits among peer trials
258 16th of 52 higher than 36 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
RECRUITING · Phase 3
-
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
RECRUITING · Phase 3
-
Psilocybin for Major Depressive Disorder (MDD)
ACTIVE NOT RECRUITING · Phase 3
-
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)
ACTIVE NOT RECRUITING · Phase 3
-
54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide
COMPLETED · Phase 3
-
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03785288 · 258 participants · Phase 3
Vaginal Cuff Brachytherapy Fractionation Study
- NCT04643002 · 258 participants · Phase 1
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
- NCT04924322 · 258 participants · Phase 2
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
- NCT05043012 · 258 participants · NA
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI