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Completed Phase 3 Interventional Results available

54135419SUI3002: 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

ClinicalTrials.gov ID: NCT03097133

Public ClinicalTrials.gov record NCT03097133. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 2:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-blind, Randomized, Placebo-controlled 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 Subjects Assessed to be at Imminent Risk for Suicide

Study identification

NCT ID
NCT03097133
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
230 participants

Conditions and interventions

Interventions

  • Esketamine Drug
  • Placebo Drug
  • Standard of Care Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 14, 2017
Primary completion
Apr 10, 2019
Completion
Apr 10, 2019
Last update posted
Apr 28, 2025

2017 – 2019

United States locations

U.S. sites
18
U.S. states
13
U.S. cities
17
Facility City State ZIP Site status
University of California San Diego/Psychiatry San Diego California 92103-8229
Sharp Mesa Vista Hospital San Diego California 92123
University of Conneticut School of Medicine Farmington Connecticut 06030
University of Miami Health System Miami Florida 33136
Innovative Clinical Research Inc North Miami Florida 33161
University of South Florida Tampa Florida 33613
Atlanta Behavioral Research, LLC Atlanta Georgia 30338
Memorial Medical Center Springfield Illinois 62702
Neuroscience Research Institute Winfield Illinois 60190
Lake Charles Clinical Trials Lake Charles Louisiana 70629
John Hopkins Hospital Baltimore Maryland 21287
Altea Research Institute Las Vegas Nevada 89102
The Zucker Hillside Hospital Glen Oaks New York 11004
Stony Brook University Medical Center Stony Brook New York 11794
University of North Carolina Chapel Hill North Carolina 27599
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience Cincinnati Ohio 45219
East Tennessee State University Johnson City Tennessee 37604
University of Wisconsin Medical Center Madison Wisconsin 53705

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03097133, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 28, 2025 · Synced Jul 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03097133 live on ClinicalTrials.gov.

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