Clinical trial
A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of…
NCT02418585 · Janssen Research & Development, LLC, Industry · Completed
Key facts
| NCT number | NCT02418585 |
|---|---|
| Title | A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression |
| Official title | A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression |
| Acronym | TRANSFORM-2 |
| Lead sponsor | Janssen Research & Development, LLC, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Treatment-resistant Depression |
| Intervention type | Drug |
| Interventions | Esketamine, Placebo, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant), Sertraline (Oral Antidepressant), Venlafaxine Extended Release (XR) (Oral Antidepressant) |
| Enrollment | 236 |
| Start date | Aug 7, 2015 |
| Primary completion | Jun 1, 2017 |
| Completion | Nov 6, 2017 |
| First posted | Apr 16, 2015 |
| Last update posted | Apr 29, 2025 |
| Countries | Czechia, Germany, Poland, Spain, 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: