Table 3.
Recent clinical trials with esketamine in treatment-resistant depression (2014 and later).
| Phase | Sponsor | Identifier | Primary outcome | Time frame | N a | Results or status |
|---|---|---|---|---|---|---|
| III | Janssen R&D (USA) | TRANSFORM-1 | MADRSd | 4 W | 348 | October 2017b |
| Janssen R&D (USA) | TRANSFORM-2 | MADRSd | 4 W | 196 | March 2017b | |
| Janssen R&D (USA) | TRANSFORM-3 | MADRSd | 4 W | 230 | July 2017b | |
| Janssen R&D (USA) | SUSTAIN-1 | Time to relapsee | 104 W | 333 | August 2017b | |
| Janssen R&D (USA) | SUSTAIN-2 | Safety | 56 W | 1071 | January 2018b | |
| II | Janssen R&D (USA) | PeRSEVERe | MADRSf | 12 W | 68 | ΔScoreg: −5.3 ± 2.1c |
| Janssen R&D (USA) | SYNAPSE | MADRSd | 2 W | 108 | July 2015b | |
| Janssen R&D (USA) | Singh et al, 2015 [64] | MADRSd | 1 D | 30 | ESKh = −16.9c, PL = −3.8 |
a
Enrolment (final or estimated).
b
Primary completion date (past or estimated).
c
Statistically significant.
d
Change from baseline in Montgomery±Asberg Depression Rating Scale (MADRS).
e
Time to relapse in patients with stable remission.
f
Change from baseline in MADRS total score at day 1 (4 h post-dose).
g
Least-square mean difference ± SE, two-sided p = 0.015.
h
Intravenous esketamine at 0.4 mg/kg.
D: days; W: weeks.