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


*For the HAM-D, the MADRS and the BDI, higher values indicate more severe impairment whereas for the SF-36, lower values indicate more severe impairment

Kasper et al. BMC Medicine 2006 4:14   doi:10.1186/1741-7015-4-14

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