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