
PBO/RIS

RIS/RIS

Directenroll

All subjects


PANSS

(n = 46)

(n = 289)

(n = 50)

(N = 385)


Total
    
Baseline, mean (SD)

84.7 (16.8)

72.1 (19.4)

83.9 (13.5)

75.1 (19.2)

Change, mean (SD)

‐25.7 (18.2)

‐10.5 (17.7)

‐19.9 (16.2)

‐13.6 (18.4)

p value

<0.001

<0.001

<0.001

<0.001

Positive symptoms
    
Baseline, mean (SD)

23.6 (6.0)

19.1 (5.7)

23.1 (4.7)

20.1 (5.9)

Change, mean (SD)

8.7 (6.5)

3.2 (5.4)

6.2 (5.2)

4.2 (5.8)

p value

<0.001

<0.001

<0.001

<0.001

Negative symptoms
    
Baseline, mean (SD)

21.5 (5.4)

19.0 (6.5)

21.2 (4.4)

19.6 (6.2)

Change, mean (SD)

5.7 (5.4)

2.9 (5.6)

4.6 (4.1)

3.4 (5.5)

p value

<0.001

<0.001

<0.001

<0.001

Anxiety/depression
    
Baseline, mean (SD)

9.7 (3.3)

8.4 (3.1)

10.1 (3.0)

8.8 (3.2)

Change, mean (SD)

3.3 (3.2)

1.2 (3.5)

2.3 (3.1)

1.6 (3.5)

p value

< 0.001

< 0.001

< 0.001

< 0.001

Disorganized thoughts
    
Baseline, mean (SD)

19.4 (4.3)

17.3 (5.7)

19.8 (4.1)

17.9 (5.4)

Change, mean (SD)

5.0 (4.1)

2.4 (4.3)

4.5 (4.3)

3.0 (4.4)

p value

<0.001

<0.001

<0.001

<0.001

Uncontrolled hostility/excitement
    
Baseline, mean (SD)

10.5 (3.6)

8.4 (3.3)

9.6 (3.1)

8.8 (3.4)

Change, mean (SD)

3.1 (4.0)

1.0 (3.5)

2.3 (3.2)

1.4 (3.6)

p value

<0.001

<0.001

<0.001

<0.001

CGAS

(n = 45)

(n = 174)

(n = 41)

(n = 260)

Baseline, mean (SD)

51.8 (16.7)

55.9 (15.5)

51.1 (15.4)

54.4 (15.8)

Change, mean (SD)

16.3 (13.7)

7.5 (14.3)

14.4 (12.2)

10.1 (14.3)

p value

<0.001

<0.001

<0.001

<0.001

 CGAS, Children’s Global Assessment Scale; PANSS, positive and negative syndrome score; PBO, placebo; RIS, risperidone; SD, standard deviation.
 ^{a}Intenttotreat population, last observation carried forward.
 Note: p values are from a withingroup test of change from baseline, based on twosided paired t test.