Table 1. Demographic and Baseline Characteristicsa.
| Characteristic | Stable Remission at Baseline | Stable Response at Baseline | ||
|---|---|---|---|---|
| Esketamine Nasal Spray and Oral Antidepressant (n = 90) | Oral Antidepressant and Placebo Nasal Spray (n = 86) | Esketamine Nasal Spray and Oral Antidepressant (n = 62) | Oral Antidepressant and Placebo Nasal Spray (n = 59) | |
| Age, mean (SD) [range], y | 45.4 (12.12) [19-64] | 46.2 (11.16) [19-64] | 47.2 (11.00) [23-63] | 46.7 (9.76) [24-64] |
| Sex | ||||
| Male | 32 (35.6) | 27 (31.4) | 24 (38.7) | 17 (28.8) |
| Female | 58 (64.4) | 59 (68.6) | 38 (61.3) | 42 (71.2) |
| Race | ||||
| American Indian or Alaskan Native | 0 | 1 (1.2) | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 (1.7) |
| Black | 4 (4.4) | 6 (7.0) | 2 (3.2) | 1 (1.7) |
| White | 80 (88.9) | 76 (88.4) | 57 (91.9) | 55 (93.2) |
| Other | 2 (2.2) | 1 (1.2) | 3 (4.8) | 1 (1.7) |
| Multiple | 1 (1.1) | 0 | 0 | 1 (1.7) |
| Not reported | 3 (3.3) | 2 (2.3) | 0 | 0 |
| Region | ||||
| Europe | 52 (57.8) | 50 (58.1) | 34 (54.8) | 35 (59.3) |
| North America | 22 (24.4) | 20 (23.3) | 18 (29.0) | 16 (27.1) |
| Brazil and Mexico | 16 (17.8) | 16 (18.6) | 10 (16.1) | 8 (13.6) |
| Age diagnosed with MDD, mean (SD) [range], y | 32.5 (11.42) [5-55] | 33.4 (11.41) [10-60] | 36.2 (13.25) [15-61] | 34.0 (10.54) [14-60] |
| Duration of current episode, mean (SD) [range], wk | 112.2 (171.30) [12-1040] | 110.5 (147.41) [9-884] | 121.6 (193.85) [13-1080] | 141.8 (254.43) [9-1248] |
| No. of previous antidepressants before screening | ||||
| ≤2 | 71 (78.9) | 62 (73.8) | 41 (66.1) | 34 (57.6) |
| >2 | 19 (21.1) | 22 (26.2) | 21 (33.9) | 25 (42.4) |
| History of suicidal ideation in previous 6 mo | 18 (20.0) | 14 (16.3) | 20 (32.3) | 14 (23.7) |
| Class of oral antidepressant | ||||
| SNRI | 62 (68.9) | 58 (67.4) | 35 (56.5) | 36 (61.0) |
| SSRI | 28 (31.1) | 28 (32.6) | 27 (43.5) | 23 (39.0) |
| Baseline MADRS total score, mean (SD) | ||||
| All patients | 37.4 (5.20) | 37.6 (4.66) | 40.1 (5.56) | 38.9 (4.92) |
| Direct-entry patientsb | 37.8 (5.28) | 37.8 (4.26) | 40.5 (4.88) | 38.5 (4.65) |
| Transfer-entry patientsc | 36.8 (5.10) | 37.3 (5.38) | 39.6 (6.22) | 39.9 (5.49) |
| Baseline PHQ-9 score, mean (SD) | 19.2 (4.16) | 19.8 (3.43) | 20.5 (4.12) | 20.4 (4.15) |
| Dose of esketamine before randomizationd | ||||
| 56 mg | 40 (44.4) | 33 (38.4) | 20 (32.3) | 19 (32.2) |
| Direct-entry patients | 14 (15.6) | 9 (10.5) | 7 (11.3) | 6 (10.2) |
| Transfer-entry 3001 patientse | 5 (5.6) | 4 (4.7) | 5 (8.1) | 3 (5.1) |
| Transfer-entry 3002 patientsf | 21 (23.3) | 20 (23.3) | 8 (12.9) | 10 (16.9) |
| 84 mg | 50 (55.6) | 53 (61.6) | 42 (67.7) | 40 (67.8) |
| Direct-entry patients | 12 (13.3) | 11 (12.8) | 8 (12.9) | 2 (3.4) |
| Transfer-entry 3001 patientse | 5 (5.6) | 6 (7.0) | 11 (17.7) | 7 (11.9) |
| Transfer-entry 3002 patientsf | 33 (36.7) | 36 (41.9) | 23 (37.1) | 31 (52.5) |
| Dosing frequency at baseline | ||||
| Weekly | 37 (41.1) | 41 (47.7) | 51 (83.6) | 43 (72.9) |
| Every other week | 53 (58.9) | 45 (52.3) | 10 (16.4) | 16 (27.1) |
| Missing | 0 | 0 | 1 | 0 |
Abbreviations: MADRS, Montgomery-Åsberg Depression Rating scale; MDD, major depressive disorder; PHQ-9, Patient Health Questionnaire 9; SNRI, serotonin-norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor.
Data are presented as number (percentage) of patients unless otherwise indicated.
Patients who achieved stable remission: 54 for esketamine nasal spray and oral antidepressant and 56 for oral antidepressant and placebo nasal spray; patients who achieved stable response: 31 for esketamine nasal spray and oral antidepressant and 41 for oral antidepressant and placebo nasal spray.
Patients who achieved stable remission: 36 for esketamine nasal spray and oral antidepressant and 30 for oral antidepressant and placebo nasal spray; patients who achieved stable response: 31 for esketamine nasal spray and oral antidepressant and 18 for oral antidepressant and placebo nasal spray.
During the optimization phase and before randomization.
The 3001 indicates transferred from Janssen-sponsored fixed-dose esketamine study TRD3001.15
The 3002 indicates transferred from Janssen-sponsored flexible-dose esketamine study TRD3002.12