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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)

From: Superior efficacy of St John's wort extract WS®5570 compared to placebo in patients with major depression: a randomized, double-blind, placebo-controlled, multi-center trial [ISRCTN77277298]

     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
  1. *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