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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2025-04-29

Study results available
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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

  • Depressive Disorder, Major

Interventions

DRUG

Esketamine

Intranasal esketamine solution 84 milligram (mg)

OTHER

Placebo

Intranasal Placebo solution

OTHER

Standard of Care

The standard of care antidepressant treatment (antidepressant monotherapy or antidepressant plus augmentation therapy) will be determined by the treating physician(s) based on clinical judgement and practice guidelines prior to randomization, and the treatment will be initiated on Day 1.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2018-12-18
Completion
2018-12-18
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Estonia
  • Germany
  • Hungary
  • Malaysia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03039192 on ClinicalTrials.gov