Clinical trial
54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal…
NCT03039192 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT03039192 |
|---|---|
| Title | 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 |
| 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 I |
| 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 | 226 |
| Start date | Jun 9, 2017 |
| Primary completion | Dec 18, 2018 |
| Completion | Dec 18, 2018 |
| First posted | Feb 1, 2017 |
| Last update posted | Apr 29, 2025 |
| Countries | Bulgaria, Estonia, Germany, Hungary, Malaysia, Slovakia, South Africa, South Korea, Spain, Taiwan, 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.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: