|
Relative decreases in HAM-D scores for subgroups of patients with a major depressive episode after 6 weeks of treatment with WS® 5570 or placebo (full analysis set, last observation carried forward) |
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| Subgroup based on baseline score |
Mean % decrease ± SD, number of patients |
p-value |
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|
|
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| 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 |
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|
|
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| 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 |
|
|
* "Moderately ill or less severe" § "Markedly ill or more severe" | ||||||
Kasper et al. BMC Medicine 2006 4:14 doi:10.1186/1741-7015-4-14 |
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