A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Public ClinicalTrials.gov record NCT04599855. 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 Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).
Study identification
- NCT ID
- NCT04599855
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 477 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Nov 4, 2020 (Actual)
- Primary completion
- Jan 31, 2024 (Actual)
- Completion
- Jan 31, 2024 (Actual)
- Last update posted
- Apr 25, 2025
2020 – 2024
United States locations
- U.S. sites
- 54
- U.S. states
- 19
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Department of Psychiatry and Behavioral Neurobiology | Birmingham | Alabama | 35294 | — |
| UAB Huntsville Regional Medical Campus | Huntsville | Alabama | 35801 | — |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | — |
| Behavioral Research Specialists LLC | Glendale | California | 91206 | — |
| CalNeuro Research | Los Angeles | California | 90025 | — |
| Pacific Research Partners | Oakland | California | 94607 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| University of California at San Diego | San Diego | California | 92103-8620 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| UCSF Nancy Friend Pritzker Psychiatry Building | San Francisco | California | 94143 | — |
| Velocity Clinical Research | Santa Ana | California | 91704 | — |
| CMB Clinical Trials | Santee | California | 92071 | — |
| University of Connecticut Health Center | Farmington | Connecticut | 06032 | — |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | — |
| Accel Research Sites | Lakeland | Florida | 33803 | — |
| APG Research LLC | Orlando | Florida | 32803 | — |
| USF, Department of Psychiatry and Behavioral Neurosciences | Tampa | Florida | 33613 | — |
| Neuroscience Research Institute | West Palm Beach | Florida | 33407 | — |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | 30338 | — |
| Psych Atlanta, P.C. | Marietta | Georgia | 30060 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Chicago Research Center | Chicago | Illinois | 60634 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Joliet Center for Clinical Research | Joliet | Illinois | 60435 | — |
| Pillar Clinical Research, LLC | Lincolnwood | Illinois | 60712 | — |
| Psychiatric Medicine Associates LLC | Skokie | Illinois | 60076 | — |
| Ascension via Christi Research | Wichita | Kansas | 67214 | — |
| University of Kansas School of Medicine | Wichita | Kansas | 67214 | — |
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | — |
| CBH Health | Gaithersburg | Maryland | 20877 | — |
| Copley Clinical | Boston | Massachusetts | 02116 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Rochester Center for Behavioral Medicine (RCBM) | Rochester Hills | Michigan | 48307 | — |
| Midwest Research Group - St. Charles Psychiatric Associates | Saint Charles | Missouri | 63304 | — |
| Clinilabs | New York | New York | 10016 | — |
| The Medical Research Network, LLC | New York | New York | 10128 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma | 73118 | — |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | — |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| The Warren Alpert Medical School of Brown University - Butler Hospital | Providence | Rhode Island | 02906 | — |
| BioBehavioral Research of Austin PC | Austin | Texas | 78759 | — |
| Relaro Medical Trials | Dallas | Texas | 75243 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75247 | — |
| Brain Health Consultants and TMS Center | Houston | Texas | 77046 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
| Family Psychiatry of The Woodlands | The Woodlands | Texas | 77381 | — |
| Grayline Research Center | Wichita Falls | Texas | 76309 | — |
| University of Virginia Center for Psychiatric Clinical Research | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04599855, 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 25, 2025 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04599855 live on ClinicalTrials.gov.