Clinical trial
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse…
NCT02493868 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT02493868 |
|---|---|
| Title | A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression |
| Official title | A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression |
| Acronym | SUSTAIN-1 |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Depressive Disorder, Treatment-Resistant |
| Intervention type | Drug |
| Interventions | Esketamine, Placebo, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant) |
| Enrollment | 719 |
| Start date | Oct 1, 2015 |
| Primary completion | Feb 15, 2018 |
| Completion | Feb 16, 2018 |
| First posted | Jul 10, 2015 |
| Last update posted | Apr 29, 2025 |
| Countries | Belgium, Brazil, Canada, Czechia, Estonia, France, Germany, Hungary, Mexico, Poland, Slovakia, Spain and 3 more |
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: