Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Pediatric Participants Assessed to be at Imminent Risk for Suicide
Public ClinicalTrials.gov record NCT03185819. 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, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) 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 Pediatric 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 assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.
Study identification
- NCT ID
- NCT03185819
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 147 participants
Conditions and interventions
Conditions
Interventions
- Intranasal Placebo Drug
- Midazolam Placebo Solution Drug
- Midazolam Drug
- Esketamine Drug
Drug
Eligibility (public fields only)
- Age range
- 9 Years to 17 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
- Oct 5, 2017 (Actual)
- Primary completion
- Mar 31, 2023 (Actual)
- Completion
- Mar 31, 2023 (Actual)
- Last update posted
- Apr 29, 2025
2017 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Institute of Living/ Hartford Hospital | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | 30338 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Neuroscience Research Institute | Winfield | Illinois | 60190 | — |
| Beacon Medical Group Clinical Research | South Bend | Indiana | 46617 | — |
| University of Iowa, Carver College of Medicine | Iowa City | Iowa | 52242 | — |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | — |
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| State University of New York at Buffalo | Buffalo | New York | 14215 | — |
| University North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati Hospital | Cincinnati | Ohio | 45219 | — |
| University Hospital of Cleveland | Cleveland | Ohio | 44106 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9063 | — |
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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03185819, 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 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03185819 live on ClinicalTrials.gov.