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Table 2 Results of efficacy measures at last observation

From: A double-blind randomized study assessing safety and efficacy following one-year adjunctive treatment with bitopertin, a glycine reuptake inhibitor, in Japanese patients with schizophrenia

 

Negative symptom

Sub-optimally controlled symptom

5 mg (n = 10)

10 mg (n = 47)

20 mg (n = 48)

5 mg (n = 5)

10 mg (n = 25)

20 mg (n = 25)

PANSS, mean (SD)

 Total score

  Baseline

78.8 (9.9)

79.7 (10.3)

80.5 (7.4)

87.2 (10.4)

88.4 (12.2)

91.0 (13.6)

  Change

−7.7 (5.7)

−11.0 (12.5)

−10.3 (15.9)

−9.4 (12.7)

−11.0 (14.0)

−7.5 (14.6)

 Negative symptom factor score

  Baseline

25.9 (4.5)

26.7 (4.7)

26.8 (4.4)

22.2 (6.2)

22.6 (5.7)

24.2 (6.4)

  Change

−4.8 (4.1)

−4.9 (4.7)

−4.9 (6.0)

−1.6 (3.7)

−3.7 (4.9)

−2.5 (4.8)

 Positive symptom factor score

  Baseline

16.9 (3.3)

17.3 (3.5)

18.0 (3.2)

26.2 (6.0)

26.4 (3.8)

26.5 (5.1)

  Change

−0.9 (0.9)

−1.7 (2.8)

−1.4 (3.8)

−4.2 (5.0)

−3.9 (4.5)

−2.1 (5.9)

 Disorganized thought/cognition factor score

  Baseline

19.3 (2.5)

19.3 (4.3)

19.2 (3.0)

18.2 (2.9)

19.2 (3.7)

20.8 (4.8)

  Change

−1.7 (1.9)

−2.5 (3.2)

−2.3 (3.6)

−1.8 (1.8)

−1.8 (3.0)

−1.4 (3.0)

 Uncontrolled hostility/excitement factor score

  Baseline

6.5 (2.0)

7.1 (2.4)

7.0 (2.3)

10.4 (4.4)

9.5 (3.2)

9.0 (2.5)

  Change

0.5 (1.2)

−0.6 (1.6)

−0.5 (2.2)

−1.0 (1.4)

−0.9 (2.3)

−0.7 (2.0)

 Anxiety/depression factor score

  Baseline

10.2 (2.4)

9.3 (2.6)

9.6 (2.8)

10.2 (2.5)

10.7 (2.7)

10.5 (2.8)

  Change

−0.8 (1.2)

−1.3 (2.2)

−1.3 (2.3)

−0.8 (1.9)

−0.8 (2.1)

−0.9 (2.5)

 Responder in each symptoma, n (%)

6 (60)

27 (57)

23 (49)

2 (40)

14 (56)

7 (28)

CGI, mean (SD)

 CGI-S of overall symptom

  Baseline

3.6 (0.5)

4.1 (0.6)

4.2 (0.6)

4.2 (0.4)

4.2 (0.5)

4.4 (0.6)

  Change

−0.1 (0.3)

−0.6 (0.9)

−0.6 (1.2)

−1.0 (1.0)

−0.8 (1.0)

−0.6 (1.0)

 CGI-S in each symptom

  Baseline

4.4 (0.7)

4.4 (0.6)

4.5 (0.7)

4.2 (0.4)

4.3 (0.6)

4.3 (0.6)

  Change

−0.8 (1.0)

−0.8 (1.0)

−0.9 (1.2)

−0.8 (1.1)

−0.9 (1.2)

−0.6 (1.2)

 CGI-I of overall symptomb, n (%)

0 (0)

8 (17)

12 (26)

1 (20)

7 (28)

3 (12)

 CGI-I in each symptomb, n (%)

2 (20)

9 (19)

12 (26)

1 (20)

6 (24)

4 (16)

PSP total score, mean (SD)

  Baseline

54.0 (16.2)

50.0 (14.2)

46.5 (16.0)

45.4 (18.8)

48.8 (15.6)

46.1 (12.5)

  Change

7.2 (7.3)

7.3 (11.1)

7.0 (13.8)

10.6 (14.4)

5.0 (7.4)

6.8 (11.6)

  1. Abbreviations: CGI clinical global impression, CGI-I CGI-improvement, CGI-S CGI-severity of illness, PANSS positive and negative syndrome scale, PSP personal and social performance, SD standard deviation
  2. a20 % or greater improvement of PANSS negative symptom factor score in the negative symptom group or of PANSS positive symptom factor score in the sub-optimally controlled symptom group. The scores in each item were transformed from 1–7 to 0–6
  3. bResponder of CGI-I is defined as a patient has a response of “very much improved” or “much improved”