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
NCT03039192 · Aspire I · 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 Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) (Last Observation Carried Forward [LOCF] Data) During Double-blind 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
56 study sites
| Facility | City | Region | Country |
|---|---|---|---|
| UAB Department of Psychiatry and Behavioral Neurobiology | Birmingham | Alabama | United States |
| Metropolitan Neuro Behavioral Institute | Chandler | Arizona | United States |
| Collaborative NeuroScience Network | Garden Grove | California | United States |
| Yale University | New Haven | Connecticut | United States |
| Rush University | Chicago | Illinois | United States |
| Alexian Behavioral Health Hospital | Hoffman Estates | Illinois | United States |
| University of Louisville Department of Psychiatry | Louisville | Kentucky | United States |
| LSU Health Sciences Center New Orleans | New Orleans | Louisiana | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | United States |
| CBH Health | Gaithersburg | Maryland | United States |
| State University of New York | Buffalo | New York | United States |
| Columbia University Medical Center | New York | New York | United States |
| Clinical Trials of America | Hickory | North Carolina | United States |
| The Ohio State University | Columbus | Ohio | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | United States |
| Regional Psychiatric Dispansery | Bulgaria | — | Bulgaria |
| Mental Health Center Prof. Dr. Ivan Temkov | Burgas | — | Bulgaria |
| State Psychiatric Hospital - Lovech | Lovech | — | Bulgaria |
| UMHAT 'Sveti Georgi'-Plovdiv | Plovdiv | — | Bulgaria |
| Military Medical Academy Multiprofile Hospital for Active Treatment Sofia | Sofia | — | Bulgaria |
| North Estonian Medical Centre Foundation | Tallinn | — | Estonia |
| Tartu University Hospital | Tartu | — | Estonia |
| Vivantes Humboldt Klinikum | Berlin | — | Germany |
| Universitatsklinikum Frankfurt | Frankfurt am Main | — | Germany |
| Klinik für Psychiatrie und Psychotherapie | Freiburg im Breisgau | — | Germany |
| Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu | Budapest | — | Hungary |
| Semmelweis Egyetem Kútvölgyi Klinikai Tömb | Budapest | — | Hungary |
| Nyiro Gyula Korhaz | Budapest | — | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | — | Hungary |
| Pecsi Tudomanyegyetem Klinikai Kozpont | Pécs | — | Hungary |
| University Kebangsaan Malaysia Medical Centre | Cheras | — | Malaysia |
| Hospital Kuala Lumpur | Kuala Lumpur | — | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | — | Malaysia |
| Hospital Tuanku Jaafar | Seremban | — | Malaysia |
| Fakultna nemocnica s poliklinikou v Ziline | Žilina | — | Slovakia |
| Flexivest 14 Research | Cape Town | — | South Africa |
| Juan Schrönen - Western Cape South Africa | Welgemoed | — | South Africa |
| Chonnam National University Hospital | Gwangju | — | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | — | South Korea |
| Kyung Hee University Medical Center | Seoul | — | South Korea |
| Samsung Medical Center | Seoul | — | South Korea |
| Seoul National University Hospital | Seoul | — | South Korea |
| Hosp. Univ. Fundacion Alcorcon | Alcorcón | — | Spain |
| Hosp Univ Vall D Hebron | Barcelona | — | Spain |
| Hosp Clinic de Barcelona | Barcelona | — | Spain |
| Inst. Internac. Neurociencias Aplicadas | Barcelona | — | Spain |
| Hosp. Univ. de Basurto | Bilbao | — | Spain |
| Hosp. Univ. Ramon Y Cajal | Madrid | — | Spain |
| Clinica Univ. de Navarra | Pamplona | — | Spain |
| Benito Menni Comp. Asist. Salut Mental | Sant Boi de Llobregat | — | Spain |
| Tri-Service Genaral Hospital | Neihu District | — | Taiwan |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | — | Taiwan |
| Chung Shan Medical University Hospital | Taichung | — | Taiwan |
| Taipei Veterans General Hospital | Taipei | — | Taiwan |
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.
NCT03039192 on ClinicalTrials.gov →
Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.
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