Table 1.
General characteristics of double-blinded randomized clinical trials included in the meta-analysis
| Study name (trial number) |
Length of DB | Mean age (SD) | Subjects | Clinical phase | Number of participants | Primary outcome measure | Study location | Intervention Frequency | Remission | Augmentation/ Monotherapy |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT02918318a | 4 wk | 43.4 (10.35) | MDD with treatment resistant to more than 2 antidepressants | II | PBO: 80 ESK 28 mg: 41 ESK 56: 40 ESK 84: 41 |
MADRS change at week 4 | Japan only | Twice weekly Fixed dose |
MADRS < 12 | Augmentation |
| Daly et al. [19] (NCT01998958) | 2 wk | 44.7 (10.0) | MDD with treatment resistant to more than 2 antidepressants | II | PBO: 33 ESK 28 mg: 11 ESK 56: 10 ESK 84: 12 |
MADRS change at day 8 | 13 in US 1 in Belgium |
Twice weekly Fixed dose |
MADRS < 10 | Augmentation |
| Canuso et al. [17] (NCT02133001) | 4 wk | 35.8 (13.03) | MDD with imminent suicide risk | II | PBO: 31 ESK 84: 35 |
MADRS change at 4 hours | 11 in US | Twice weekly Fixed dose |
MADRS < 12 | Augmentation |
| Fedgchin et al. [29] TRANSFORM-1 (NCT02417064) |
4 wk | 46.3 (11.16) | MDD with treatment resistant to more than 2 antidepressants | III | PBO: 80 ESK 28 mg: 41 ESK 56: 40 ESK 84: 41 |
MADRS change at week 4 | 91 centers in 9 countries |
Twice weekly Fixed dose |
MADRS < 12 | Augmentation |
| Popova et al. [20] TRANSFORM-2 (NCT02418585) |
4 wk | 45.7 (11.89) | MDD with treatment resistant to more than 2 antidepressants | III | PBO: 114 ESK 56−84 mg: 109 |
MADRS change at week 4 | 39 centers in 5 countries | Twice weekly Flexible dose |
MADRS < 12 | Augmentation |
| Ochs-Ross et al. [21] TRANSFORM-3 (NCT02422186) |
4 wk | 70 (4.52) | MDD (age > 65) with treatment resistant to more than 2 antidepressants | III | PBO: 65 ESK 28−84 mg: 72 |
MADRS change at week 4 | 69 centers in 12 countries | Twice weekly Flexible dose |
MADRS < 12 | Augmentation |
| Fu et al. [15] ASPIRE-1 (NCT03039192) |
25-day | 39.3 (12.88) | MDD with suicide intent/idea | III | PBO: 112 ESK 56−84 mg: 112 |
MADRS change at 24 hrs | 51 sites in US, Europe, Asia, and South Africa | Twice weekly Flexible dose |
MADRS < 12 | Augmentation |
| Ionescu et al. [16] ASPIRE-2 (NCT03097133) |
25-day | 40.8 (13.07) | MDD with suicide intent/idea | III | PBO: 113 ESK 56−84 mg: 114 |
MADRS change at 24 hrs | 47 centers in 13 countries | Twice weekly Flexible dose |
MADRS < 12 | Augmentation |
DB, double-blinded phse; SD, standard deviation; MDD, major depressive disorder; PBO, placebo; ESK, esketamine; MADRS, Montgomery-Åsberg depression rating scale; US, United States.
aUnpublished study.