Table 2

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

Open Data