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
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this 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.
Study identification
- NCT ID
- NCT03097133
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 230 participants
Conditions and interventions
Conditions
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 Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03097133 live on ClinicalTrials.gov.