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
Public ClinicalTrials.gov record NCT03039192. 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 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.
Study identification
- NCT ID
- NCT03039192
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 226 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 9, 2017 (Actual)
- Primary completion
- Dec 18, 2018 (Actual)
- Completion
- Dec 18, 2018 (Actual)
- Last update posted
- Apr 29, 2025
2017 – 2018
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Department of Psychiatry and Behavioral Neurobiology | Birmingham | Alabama | 35294 | — |
| Metropolitan Neuro Behavioral Institute | Chandler | Arizona | 85226 | — |
| Collaborative NeuroScience Network | Garden Grove | California | 92845 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| Rush University | Chicago | Illinois | 60612 | — |
| Alexian Behavioral Health Hospital | Hoffman Estates | Illinois | 60169 | — |
| University of Louisville Department of Psychiatry | Louisville | Kentucky | 40202 | — |
| LSU Health Sciences Center New Orleans | New Orleans | Louisiana | 70115 | — |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | — |
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| State University of New York | Buffalo | New York | 14215 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Clinical Trials of America | Hickory | North Carolina | 28601 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | — |
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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03039192, 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 29, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03039192 live on ClinicalTrials.gov.