Introduction
Methods
Study design and participants
Patient-reported outcomes
Beck Hopelessness Scale [29, 30]
Quality of Life in Depression Scale [36]
European Quality of Life Group, 5-Dimension, 5-Level [38]
Treatment Satisfaction Questionnaire for Medication, 9 Items [42]
Statistical analyses
Results
Patient disposition and characteristics
Parameter | Esketamine + SOC (n = 226) | Placebo + SOC (n = 225) |
---|---|---|
Age, mean | 40.5 | 39.6 |
Female, n (%) | 134 (59.3) | 140 (62.2) |
Race, n (%) | ||
African American | 11 (4.9) | 15 (6.7) |
Asian | 29 (12.8) | 30 (13.3) |
Caucasian | 169 (74.8) | 161 (71.6) |
Other/multiple | 11 (4.9) | 11 (4.9) |
Not reported | 6 (2.7) | 8 (3.6) |
Ethnicity, n (%) | ||
Hispanic or Latino | 38 (16.8) | 36 (16.0) |
Not Hispanic or Latino | 181 (80.1) | 180 (80.0) |
Unknown | 1 (0.44) | 1 (0.44) |
BHS total score, mean (SD) | 15.4 (4.2) | 15.8 (4.3) |
QLDS score, mean (SD) | 27.0 (6.3) | 27.0 (5.8) |
Health status index, mean (SD) | 0.56 (0.20) | 0.56 (0.20) |
EQ-VAS score, mean (SD) | 40.1 (23.6) | 40.2 (23.8) |
Patient-reported outcomes
Beck Hopelessness Scale
Esketamine + SOC (n = 226) | Placebo + SOC (n = 225) | |||
---|---|---|---|---|
n | Mean (SD) | n | Mean (SD) | |
BHS total score | ||||
Baseline | 224 | 15.4 (4.2) | 224 | 15.8 (4.3) |
Day 25 | 197 | 8.2 (6.6) | 195 | 8.9 (6.6) |
Change from baseline | 196 | − 7.4 (6.7) | 194 | − 6.8 (6.5) |
Difference of LS means (95% CI) | − 1.0 (− 2.23; 0.21) | |||
QLDS score | ||||
Baseline | 225 | 27.0 (6.3) | 224 | 27.0 (5.8) |
Day 25 | 196 | 12.6 (11.3) | 193 | 14.7 (10.8) |
Change from baseline | 196 | − 14.4 (11.5) | 192 | − 12.2 (10.9) |
Difference of LS means (95% CI) | − 3.1 (− 5.21; − 1.02) | |||
HSI | ||||
Baseline | 225 | 0.56 (0.20) | 224 | 0.56 (0.20) |
Day 25 | 196 | 0.79 (0.17) | 193 | 0.76 (0.18) |
Change from baseline | 196 | 0.23 (0.21) | 192 | 0.19 (0.22) |
EQ-VAS score | ||||
Baseline | 225 | 40.1 (23.62) | 224 | 40.2 (23.82) |
Day 25 | 196 | 64.3 (22.34) | 193 | 60.5 (22.41) |
Change from baseline | 196 | 24.0 (27.18) | 192 | 19.3 (24.39) |
Esketamine + SOC (n = 226) | Placebo + SOC (n = 225) | |
---|---|---|
QLDS change from baseline to day 25 ≤ -8, n (%) | 132 (58.4) | 113 (50.2) |
Difference in % (95% CI) | 8.2 (− 0.98; 17.35) | |
HSI change from baseline to day 25 ≥ 0.03, n (%) | 168 (74.3) | 147 (65.3) |
Difference in % (95% CI) | 9.0 (0.57; 17.43) | |
HSI change from baseline to day 25 ≥ 0.07, n (%) | 152 (67.3) | 134 (59.6) |
Difference in % (95% CI) | 7.7 (− 1.16; 16.56) | |
EQ-VAS change from baseline to day 25 ≥ 7, n (%) | 139 (61.5) | 126 (56.0) |
Difference in % (95% CI) | 5.5 (− 3.57; 14.58) | |
EQ-VAS change from baseline to day 25 ≥ 10, n (%) | 137 (60.6) | 121 (53.8) |
Difference in % (95% CI) | 6.8 (− 2.27; 15.95) | |
BHS at day 25 < 9, n (%) | 112 (49.6) | 100 (44.4) |
Difference in % (95% CI) | 5.1 (− 4.09; 14.31) |