Table 1.
Characteristics of the three short-term esketamine efficacy trials submitted to the FDA
| Reference number | Participants | N | Treatment (N) | Treatment2 (N) | Control (N) | Duration (weeks) | Outcome |
|---|---|---|---|---|---|---|---|
| TRANSFORM 1 (NCT02417064) |
Adults with TRD, age <65 | 342 | Esketamine 56 mg + AD (115) | Esketamine 84 mg + AD (114) | Placebo + AD (113) | 4 | Change from baseline to day 28 at the MADRS |
| TRANSFORM 2 (NCT02418585) |
Adults with TRD, age <65 | 223 | Esketamine flexible dose + AD (114) | – | Placebo + AD (114) | 4 | Change from baseline to day 28 at MADRS |
| TRANSFORM 3 (NCT02422186) |
Elderly with TRD, age >65 | 137 | Esketamine flexible dose + AD (72) | – | Placebo + AD (65) | 4 | Change from baseline to day 28 at MADRS |
MADRS, Montgomery–Asberg Depression Rating Scale; TRD, treatment-resistant depression; AD, antidepressant.