Clinical trial
A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in…
NCT01998958 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT01998958 |
|---|---|
| Title | A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression |
| Official title | A Double-Blind, Doubly-Randomized, Placebo-Controlled Study of Intranasal Esketamine in an Adaptive Treatment Protocol to Assess Safety and Efficacy in Treatment-Resistant Depression (SYNAPSE) |
| Acronym | SYNAPSE |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Treatment Resistant Depressive Disorder |
| Intervention type | Drug |
| Interventions | Esketamine 14 mg, Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg, Placebo |
| Enrollment | 108 |
| Start date | Jan 27, 2014 |
| Primary completion | Jul 21, 2015 |
| Completion | Sep 25, 2015 |
| First posted | Dec 3, 2013 |
| Last update posted | Apr 29, 2025 |
| Countries | Belgium, Japan, United States |
At a glance
- 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: