Subgroup based on baseline score | Mean % decrease ± SD, number of patients | p-value | ||||
---|---|---|---|---|---|---|
WS® 5570 600 mg/day N = 119 | WS® 5570 1200 mg/day N = 124 | Placebo N = 81 | WS® 5570 600 mg/day vs placebo | WS® 5570 1200 mg/day vs placebo | ||
Baseline HAM-D total score cutoff 20 (split at 25th percentile) | <20 | 54.2 ± 26.3, 25 | 56.0 ± 29.9, 31 | 32.7 ± 40.5, 14 | 0.09 | 0.07 |
≥ 20 | 51.1 ± 28.3, 94 | 46.4 ± 32.5, 93 | 24.4 ± 33.6, 67 | <0.001 | <0.001 | |
Baseline HAM-D total score cutoff 23 (split at median) | <23 | 55.5 ± 28.1, 56 | 53.1 ± 29.7, 64 | 26.8 ± 38.8, 37 | <0.001 | <0.001 |
≥ 23 | 48.4 ± 27.4, 63 | 44.2 ± 33.9, 60 | 25.1 ± 31.4, 44 | <0.001 | <0.01 | |
Baseline HAM-D total score cutoff 25 (split at 75th percentile) | <25 | 53.6 ± 27.3, 83 | 52.8 ± 30.2, 85 | 28.6 ± 37.7, 49 | <0.001 | <0.001 |
≥ 25 | 47.4 ± 28.9, 36 | 40.2 ± 34.5, 39 | 21.7 ± 29.8, 32 | <0.001 | 0.02 | |
Baseline CGI item 1, severity of illness | <5* | 51.2 ± 28.7, 67 | 49.9 ± 31.5, 62 | 28.0 ± 36.1, 46 | <0.001 | <0.01 |
≥ 5§ | 52.4 ± 26.9, 52 | 47.7 ± 32.7, 62 | 23.1 ± 33.3, 35 | <0.001 | <0.001 |