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COMPLETED 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

NCT03039192 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

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

Sponsor

Janssen Research & Development

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03039192

The ClinicalTrials.gov registry entry for NCT03039192 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03039192 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Illinois, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03039192?

The interventions under investigation include: Placebo (OTHER), Standard of Care (OTHER), Esketamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03039192?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial