Table 4.
Baseline Characteristics and Psychiatric History by Treatment Frequency of Esketamine Nasal Spray in SUSTAIN-2
| Weekly n = 138 | Switched once from weekly to every other week n = 221 | Alternating between weekly and every other week n = 221 | All patients n = 580a | |
|---|---|---|---|---|
| Age, mean (SD), y | 51.6 (13.56) | 51.2 (12.44) | 49.7 (14.03) | 50.7 (13.33) |
| Sex, n (% of all patients) | ||||
| Male | 57 (41.3%) | 76 (34.4%) | 79 (35.7%) | 212 (36.6%) |
| Female | 81 (58.7%) | 145 (65.6%) | 142 (64.3%) | 368 (63.4%) |
| Race, n (% of all patients) | ||||
| White | 117 (84.8%) | 195 (88.2%) | 185 (83.7%) | 497 (85.7%) |
| Asian | 16 (11.6%) | 20 (9.1%) | 19 (8.6%) | 55 (9.5%) |
| Black or African American | 2 (1.4%) | 3 (1.4%) | 8 (3.6%) | 13 (2.2%) |
| Other | 0 (0.0%) | 1 (0.5%) | 6 (2.7%) | 7 (1.2%) |
| Multiple | 3 (2.2%) | 1 (0.5%) | 2 (0.9%) | 6 (1.0%) |
| Not reported | 0 (0.0%) | 1 (0.5%) | 1 (0.5%) | 2 (0.3%) |
| Ethnicity, n (% of all patients) | ||||
| Hispanic or Latino | 26 (18.8%) | 68 (30.8%) | 36 (16.3%) | 130 (22.4%) |
| Not Hispanic or Latino | 111 (80.4%) | 151 (68.3%) | 183 (82.8%) | 445 (76.7%) |
| Not reported/unknown | 1 (0.7%) | 2 (0.9%) | 2 (0.9%) | 5 (0.9%) |
| Baseline BMI, mean (SD), kg/m2 | 28.4 (5.72) | 27.7 (5.46) | 28.2 (6.20) | 28.0 (5.81) |
| Region, n (% of all patients) | ||||
| Europe | 43 (31.2%) | 88 (39.8%) | 79 (35.7%) | 210 (36.2%) |
| North America | 25 (18.1%) | 23 (10.4%) | 47 (21.3%) | 95 (16.4%) |
| Other | 70 (50.7%) | 110 (49.8%) | 95 (43.0%) | 275 (47.4%) |
| Oral antidepressant, n (% of all patients) | ||||
| Duloxetine | 47 (34.1%) | 72 (32.6%) | 69 (31.2%) | 188 (32.4%) |
| Escitalopram | 37 (26.8%) | 71 (32.1%) | 61 (27.6%) | 169 (29.1%) |
| Sertraline | 24 (17.4%) | 32 (14.5%) | 40 (18.1%) | 96 (16.6%) |
| Venlafaxine XR | 30 (21.7%) | 46 (20.8%) | 51 (23.1%) | 127 (21.9%) |
| Baseline CGI-S score, mean (SD) | 4.9 (0.71) | 4.7 (0.78) | 4.8 (0.78) | 4.8 (0.77) |
| Baseline MADRS total score, mean (SD) | 31.9 (5.15) | 30.3 (4.80) | 31.1 (5.12) | 31.0 (5.04) |
| Baseline PHQ-9 total score, mean (SD) | 18.5 (4.89) | 16.6 (4.74) | 17.2 (5.11) | 17.3 (4.96) |
| Age at MDD diagnosis, mean (SD), y | 35.8 (14.24) | 34.9 (12.64) | 33.7 (12.33) | 34.7 (12.93) |
| History of suicidal ideationa (based on C-SSRS) in the past 6 months, n (%) | 33 (23.9) | 41 (18.6) | 71 (32.1) | 145 (25.0) |
| Duration of current episode, wk | ||||
| Mean, median | 175.9, 60 | 147.7, 52 | 153.1, 78 | 156.6, 63.5 |
| Minimum–maximum | 6–1872 | 6–2184 | 10–1196 | 6–2184 |
| Previous MDD episodes, including current episodes, n (% of all patients) | ||||
| 1 | 18 (13.0%) | 26 (11.8%) | 32 (14.5%) | 76 (13.1%) |
| 2–5 | 87 (63.0%) | 161 (72.9%) | 140 (63.3%) | 388 (66.9%) |
| 6–10 | 23 (16.7%) | 27 (12.2%) | 42 (19.0%) | 92 (15.9%) |
| >10 | 10 (7.2%) | 7 (3.2%) | 7 (3.2%) | 24 (4.1%) |
| Family history of bipolar disorder, n (% of all patients) | ||||
| Yes | 2 (1.4%) | 7 (3.2%) | 6 (2.7%) | 15 (2.6%) |
| No | 136 (98.6%) | 214 (96.8%) | 215 (97.3%) | 565 (97.4%) |
Abbreviations: BMI, body mass index; CGI-S, Clinical Global Impression–Severity; C-SSRS, Columbia Suicide Severity Rating Scale; MADRS, Montgomery-Åsberg Depression Rating Scale; MDD, major depression disorder; PHQ-9, Patient Health Questionnaire 9-item.
a23 responders from TRANSFORM-3 were excluded from the analysis.
bActive suicidal ideation or behavior was an exclusion criterion for entry into the study.