Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03039192 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
226
Enrollment target
20
Study locations

NCT03039192: Completed Phase 3 study of Depressive Disorder, Major, sponsored by Janssen Research & Development.

NCT03039192 is a Phase 3 study of Depressive Disorder, Major that has completed, run by Janssen Research & Development. The registered enrollment target is 226 participants, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03039192, a Phase 3 study of Depressive Disorder, Major, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
226 participants
Enrollment target
20
Study locations

Study Summary

The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

Primary Outcome

MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total

Conditions Studied

Depressive Disorder, Major

Interventions

  • OTHER Placebo
  • OTHER Standard of Care
  • DRUG Esketamine

Study Locations (20)

Other

  • Regional Psychiatric Dispansery - Bulgaria
  • Mental Health Center Prof. Dr. Ivan Temkov - Burgas
  • State Psychiatric Hospital - Lovech - Lovech

Illinois

  • Rush University - Chicago
  • Alexian Behavioral Health Hospital - Hoffman Estates

Louisiana

  • LSU Health Sciences Center New Orleans - New Orleans
  • Louisiana Clinical Research - Shreveport

Maryland

  • Sheppard Pratt Health System - Baltimore
  • CBH Health - Gaithersburg

New York

  • State University of New York - Buffalo
  • Columbia University Medical Center - New York

Alabama

  • UAB Department of Psychiatry and Behavioral Neurobiology - Birmingham

Arizona

  • Metropolitan Neuro Behavioral Institute - Chandler

California

  • Collaborative NeuroScience Network - Garden Grove

Trial Details

FieldValue
Enrollment Target 226 participants
Start Date 2017-06-09
Est. Completion 2018-12-18
Phase Phase 3
Janssen Research & Development

593 total trials

What the finished NCT03039192 record still lists

NCT03039192 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 238-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 3 interventions - of which Placebo is the first listed.

NCT03039192 names 20 study sites across 14 states, led by Other, Illinois, Louisiana.

Frequently Asked Questions

What is clinical trial NCT03039192 about?

NCT03039192 is a clinical study titled "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". The purpose of the study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to...

What is the current status of trial NCT03039192?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2017-06-09. Estimated completion is 2018-12-18.

What conditions does trial NCT03039192 study?

This clinical trial studies the following conditions: Depressive Disorder, Major.

What interventions are being tested in trial NCT03039192?

The interventions under investigation include: Placebo (OTHER), Standard of Care (OTHER), Esketamine (DRUG).

Who is sponsoring clinical trial NCT03039192?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03039192 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Illinois. 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 NCT03039192's enrollment target sits among peer trials

226 21st of 52 higher than 32 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

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

  • NCT04419272 · 226 participants · Phase 4

    Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

  • NCT05449002 · 226 participants · NA

    Digital Single Session Intervention for Youth Mental Health

  • NCT05488054 · 226 participants · NA

    Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

  • NCT05924477 · 226 participants · NA

    Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

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

Related registry views

Source: ClinicalTrials.gov NCT03039192, the US trial registry maintained by the National Library of Medicine. NCT03039192 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.