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
NCT03097133 · Aspire II · Janssen Research & Development, LLC
What it is testing
Summary
Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.
What counts as success
Primary outcome measures
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose (Last Observation Carried Forward [LOCF] Data): Double-blind (DB) Treatment Phase
Measured over Baseline (Day 1, predose) and 24 hours first post dose (Day 2)
Change From Baseline in Clinical Global Impression-Severity of Suicidality - Revised (CGI-SS-R) Scale at 24 Hours Post First Dose (LOCF Data): DB Treatment Phase
Measured over Baseline (Day 1, predose) and 24 hours first post dose (Day 2)
A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.
Who can take part
Eligibility, as published
Where
61 study sites
| Facility | City | Region | Country |
|---|---|---|---|
| University of California San Diego/Psychiatry | San Diego | California | United States |
| Sharp Mesa Vista Hospital | San Diego | California | United States |
| University of Conneticut School of Medicine | Farmington | Connecticut | United States |
| University of Miami Health System | Miami | Florida | United States |
| Innovative Clinical Research Inc | North Miami | Florida | United States |
| University of South Florida | Tampa | Florida | United States |
| Atlanta Behavioral Research, LLC | Atlanta | Georgia | United States |
| Memorial Medical Center | Springfield | Illinois | United States |
| Neuroscience Research Institute | Winfield | Illinois | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | United States |
| John Hopkins Hospital | Baltimore | Maryland | United States |
| Altea Research Institute | Las Vegas | Nevada | United States |
| The Zucker Hillside Hospital | Glen Oaks | New York | United States |
| Stony Brook University Medical Center | Stony Brook | New York | United States |
| University of North Carolina | Chapel Hill | North Carolina | United States |
| University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience | Cincinnati | Ohio | United States |
| East Tennessee State University | Johnson City | Tennessee | United States |
| University of Wisconsin Medical Center | Madison | Wisconsin | United States |
| Clínica Privada Banfield S.A | Banfield | — | Argentina |
| Hospital Fleni | Ciudad de Buenos Aires | — | Argentina |
| Sanatorio Prof. Leon S. Morra | Córdoba | — | Argentina |
| Clinica Privada de Salud Mental Santa Teresa de Ávila | La Plata | — | Argentina |
| Medical University Vienna MUV | Vienna | — | Austria |
| Klinikum Wels Grieskirchen | Wels | — | Austria |
| AZ Sint Jan Brugge Oostende AV | Bruges | — | Belgium |
| UZ Gent | Ghent | — | Belgium |
| ARIADNE | Lede | — | Belgium |
| Universidade Federal De Minas Gerais - Hospital das Clínicas | Belo Horizonte | — | Brazil |
| Universidade Federal Do Ceara | Fortaleza | — | Brazil |
| Instituto Bairral de Psiquiatria | Itapira | — | Brazil |
| Hospital Universitario Professor Edgar Santos | Salvador | — | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | Santo André | — | Brazil |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP | São Paulo | — | Brazil |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Institut universitaire en sante mentale de Montreal | Montreal | Quebec | Canada |
| Fakultni nemocnice Brno | Brno | — | Czechia |
| Nemocnice s pol. Havirov, p.o. | Havířov | — | Czechia |
| Narodni ustav dusevniho zdravi | Klecany | — | Czechia |
| Vseobecna Fakultní Nemocnice | Prague | — | Czechia |
| Ústrední vojenské nemocnice Praha | Prague | — | Czechia |
| Hôpital de Bohars | Bohars | — | France |
| CHRU Montpellier Hopital Lapeyronie | Montpellier | — | France |
| CHU Caremeau | Nîmes | — | France |
| Hopital Sainte Anne | Paris | — | France |
| CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | — | France |
| CHU Toulouse | Toulouse | — | France |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas | — | Lithuania |
| Republic Kaunas Hospital | Kaunas County | — | Lithuania |
| Vilnius Mental Health Center | Vilnius | — | Lithuania |
| Uniwersyteckie Centrum Kliniczne | Gdansk | — | Poland |
| Szpital Specjalistyczny im H Klimontowicza Oddzial Psychiatryczny | Gorlice | — | Poland |
| SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych | Lodz | — | Poland |
| Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana Mazurkiewicza | Pruszków | — | Poland |
| Hosp Univ Vall D Hebron | Barcelona | — | Spain |
| Inst. Internac. Neurociencias Aplicadas | Barcelona | — | Spain |
| Hosp. Univ. de Basurto | Bilbao | — | Spain |
| Clinica Univ. de Navarra | Pamplona | — | Spain |
| Bursa Sevket Yilmaz Research and Training Hospital | Bursa | — | Turkey (Türkiye) |
| Uludag University Medical Faculty | Bursa | — | Turkey (Türkiye) |
| Sisli Etfal Research Training Hospital | Istanbul | — | Turkey (Türkiye) |
| Samsun Psychiatric Hospital | Samsun | — | Turkey (Türkiye) |
On the registry
Contact the trial directly
This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.
Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.
NCT03097133 on ClinicalTrials.gov →
Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.
Related