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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07227454
The ClinicalTrials.gov registry entry for NCT07227454 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 237-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.