Table 4 Secondary efficacy measures for patients with a major depressive episode treated over 6-weeks with WS® 5570 or placebo (full analysis set, last observation carried forward)
p-value | |||||
|---|---|---|---|---|---|
Secondary efficacy measure* | 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 |
n (%) | |||||
Responder rate (decrease ≥ 50% in total HAM-D score between day 0 and day 42) | 83 (69.8) | 76 (61.3) | 26 (31.1) | <0.001 | <0.001 |
Remission rate (≤ 7 points in total HAM-D score at day 42) | 39 (32.8) | 50 (40.3) | 12 (14.8) | <0.01 | <0.001 |
CGI, item 1: | |||||
improved by ≥ 2 categories | 46 (38.7) | 54 (43.6) | 14 (17.3) | 0.001 | <0.001 |
CGI, item 2: | |||||
much or very much improved | 76 (63.9) | 77 (62.1) | 25 (30.9) | <0.001 | <0.001 |
CGI, item 3: | |||||
marked therapeutic effect | 40 (33.6) | 47 (37.9) | 13 (16.1) | 0.006 | <0.001 |
Mean ± SD | |||||
MADRS absolute change | |||||
day 14 – day 0 | -5.3 ± 7.7 | -4.4 ± 5.5 | -5.0 ± 6.6 | 0.80 | 0.46 |
day 42 – day 0 | -13.3 ± 9.3 | -11.8 ± 9.3 | -6.5 ± 10.4 | <0.001 | <0.001 |
MADRS relative decrease (%) | |||||
day 14 – day 0 | 19.5 ± 26.7 | 17.5 ± 22.8 | 18.1 ± 25.1 | 0.72 | 0.85 |
day 42 – day 0 | 48.9 ± 31.6 | 45.6 ± 34.2 | 22.2 ± 36.6 | <0.001 | <0.001 |
BDI absolute change | |||||
(day 42 – day 0) | -8.3 ± 8.5 | -8.0 ± 9.1 | -3.7 ± 7.9 | <0.001 | <0.001 |
BDI relative change (%) | |||||
day 42 – day 0 | 34.6 ± 34.0 | 34.1 ± 36.8 | 14.2 ± 36.9 | <0.001 | <0.001 |
SF-36 summary measures (day 42 – day 0) | |||||
Physical health | 3.8 ± 18.3 | 5.8 ± 16.3 | 2.2 ± 13.7 | 0.47 | 0.09 |
Mental health | 18.1 ± 18.7 | 16.5 ± 21.9 | 6.8 ± 14.6 | <0.001 | <0.001 |