Clinical trial
54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal…
NCT03097133 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT03097133 |
|---|---|
| Title | 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 |
| 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… |
| Acronym | Aspire II |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Depressive Disorder, Major |
| Intervention type | Drug, Other |
| Interventions | Esketamine, Placebo, Standard of Care |
| Enrollment | 230 |
| Start date | Jun 15, 2017 |
| Primary completion | Apr 11, 2019 |
| Completion | Apr 11, 2019 |
| First posted | Mar 31, 2017 |
| Last update posted | Apr 29, 2025 |
| Countries | Argentina, Austria, Belgium, Brazil, Canada, Czechia, France, Lithuania, Poland, Spain, Turkey (Türkiye), United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: