|
Comparison of HAM-D scores for patients with a major depressive episode over 6-week treatment with WS® 5570 or placebo (full analysis set; last observation carried forward) |
||||||
| HAM-D measure |
WS® 5570 600 mg/day N = 119 |
WS® 5570 1200 mg/day N = 124 |
Placebo N = 81 |
p-value |
||
|
|
||||||
| WS® 5570 600 mg/day vs placebo |
WS® 5570 1200 mg/day vs placebo |
|||||
|
|
||||||
| Total score (mean ± SD) |
Day 0 |
22.8 ± 3.3 |
22.6 ± 3.8 |
23.6 ± 4.2 |
0.14 |
0.09 |
| Day 14 |
17.9 ± 6.3 |
18.2 ± 6.6 |
19.1 ± 20 |
0.23 |
0.34 |
|
| Day 42 |
11.2 ± 7.0 |
11.8 ± 8.3 |
17.6 ± 8.8 |
<0.001 |
<0.001 |
|
| Difference vs day 0 (mean ± SD) |
Day 14 |
-4.9 ± 5.1 |
-4.5 ± 4.7 |
-4.5 ± 5.4 |
0.65 |
0.95 |
| Day 42 |
-11.6 ± 6.4 |
-10.8 ± 7.3 |
-6.0 ± 8.1 |
<0.001 |
<0.001 |
|
| Mean reduction vs day 0 (%) |
Day 14 |
22.0% |
20.9% |
16.7% |
0.54 |
0.77 |
| Day 42 |
57.9% |
57.1% |
16.7% |
<0.001 |
<0.001 |
|
|
|
||||||
| Comparison vs placebo for difference day 42 vs day 0 |
WS® 5570 600 mg/day vs placebo |
WS® 5570 1200 mg/day vs placebo |
||||
| Differences in means* |
-5.6 |
-4.8 |
||||
| 95% confidence interval |
[-7.7, -3.6] |
[-6.9, -2.6] |
||||
| p-value |
<0.001 |
<0.001 |
||||
|
*A negative difference denotes a more favorable outcome in the treatment group named first. | ||||||
Kasper et al. BMC Medicine 2006 4:14 doi:10.1186/1741-7015-4-14 |
||||||