Table 2. Response and Remission Rates for Participants Who Completed the OL and Follow-up Phasesa.
| Variable | Placebo/Placebo/OL Esketamine (n = 10)b | Placebo/Esketamine/OL Esketamine (n = 20) | Esketamine/Esketamine/OL Esketamine (n = 27) | Total (n = 57) |
|---|---|---|---|---|
| Response Ratec | ||||
| OL end point, day 74, No. | 6 | 10 | 18 | 34 |
| ≥50% Improvement, No. (%) | 6 (100) | 5 (50) | 11 (61) | 22 (65) |
| Week 8 (follow-up), No. | 7 | 12 | 22 | 41 |
| ≥50% Improvement, No. (%) | 5 (71) | 3 (25) | 15 (68) | 23 (56) |
| Remission Ratec | ||||
| OL end point, day 74, No. | 6 | 10 | 18 | 34 |
| No, No. (%) | 4 (67) | 6 (60) | 13 (72) | 23 (68) |
| Yes, No. (%) | 2 (33) | 4 (40) | 5 (28) | 11 (32) |
| Week 8 (follow-up), No. | 7 | 12 | 22 | 41 |
| No, No. (%) | 3 (43) | 9 (75) | 12 (55) | 24 (59) |
| Yes, No. (%) | 4 (57) | 3 (25) | 10 (46) | 17 (42) |
Abbreviation: OL, open-label.
a
The follow-up phase includes data from 7 participants enrolled under the original version of the protocol in which participants received 2 weeks of study drug during the OL phase of the study and data from 50 participants enrolled under a protocol amendment in which participants received up to 9 weeks of study drug during the OL phase of the study. Percentages calculated with the number of participants per a visit as denominator; percentage change calculated based on period 1 baseline.
b
Esketamine was given as esketamine hydrochloride.
c
Response: Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥50%; remission: MADRS total score ≤10.