| |
Median score
|
Mean (SD) score
|
Median change from screening to week 12
|
|---|
|
Screening (n = 18)
|
Week 12 (n = 18)
|
Screening (n = 18)
|
Week 12 (n = 18)
|
Score (% change)
|
Paired-samples t test
|
|---|
|
t
|
Cohen’s d
|
|---|
|
Primary efficacy measures
|
|
ADAMS
|
|
Total
|
32.00
|
18.00
|
32.10 (14.36)
|
18.10 (8.32)
|
− 15.50 (− 48.90%)
|
− 5.74***
|
1.36
|
|
Manic/hyperactive
|
9.00
|
6.00
|
8.80 (3.99)
|
6.10 (3.29)
|
− 2.50 (− 32.50%)
|
− 4.51***
|
1.05
|
|
Depressed mood
|
2.00
|
1.00
|
2.90 (3.94)
|
2.00 (2.35)
|
0.00
|
− 1.54
|
0.37
|
|
Social avoidance
|
10.00
|
5.00
|
9.90 (5.18)
|
4.80 (2.07)
|
− 5.50 (− 55.40%)
|
− 4.79***
|
1.14
|
|
General anxiety
|
10.00
|
4.50
|
9.40 (4.35)
|
4.60 (3.35)
|
− 5.00 (− 52.30%)
|
− 7.19***
|
1.70
|
|
Compulsive behavior
|
2.50
|
1.50
|
2.70 (2.40)
|
1.40 (1.42)
|
− 2.00 (− 57.10%)
|
− 2.43*
|
0.56
|
|
Secondary efficacy measures
|
|
ABC-CFXS
|
|
Social avoidance
|
4.50
|
2.50
|
5.10 (3.46)
|
2.30 (2.22)
|
− 3.00 (− 66.70%)
|
− 4.31***
|
1.00
|
|
Stereotypy
|
8.50
|
2.00
|
8.10 (5.91)
|
3.20 (3.07)
|
− 5.00 (− 69.00%)
|
− 4.20***
|
0.99
|
|
Socially unresponsive/lethargic
|
8.00
|
4.00
|
9.20 (6.40)
|
4.10 (4.09)
|
− 5.00 (− 65.20%)
|
− 3.40**
|
0.76
|
|
Irritability
|
18.50
|
8.50
|
17.70 (12.68)
|
10.60 (11.03)
|
− 7.50 (− 50.00%)
|
− 2.92**
|
0.69
|
|
Hyperactivity
|
10.50
|
8.50
|
13.70 (9.09)
|
9.80 (7.38)
|
− 3.50 (− 29.80%)
|
− 2.49*
|
0.59
|
|
Inappropriate speech
|
6.00
|
3.50
|
5.90 (2.30)
|
3.50 (2.66)
|
− 3.00 (− 44.40%)
|
− 3.69**
|
0.87
|
|
PARS-R
|
|
Total severity (5-item)
|
14.50
|
9.50
|
15.70 (3.88)
|
10.60 (3.43)
|
− 6.00 (− 38.20%)
|
− 4.18***
|
0.98
|
|
PedsQL
|
|
Total score
|
65.20
|
67.80
|
57.80 (18.78)
|
67.70 (18.27)
|
9.80 (16.70%)
|
2.98*
|
0.77
|
|
Physical functioning
|
68.80
|
79.70
|
67.90 (27.36)
|
78.00 (22.39)
|
6.30 (7.10%)
|
2.04
|
0.53
|
|
Emotional functioning
|
60.00
|
80.00
|
64.00 (20.72)
|
78.30 (16.63)
|
10.00 (11.10%)
|
2.27*
|
0.58
|
|
Social functioning
|
40.00
|
50.00
|
37.30 (24.70)
|
49.00 (24.35)
|
10.00 (27.80%)
|
1.95
|
0.50
|
|
School functioning
|
55.00
|
55.00
|
55.70 (19.17)
|
59.10 (22.47)
|
0.00
|
0.95
|
0.25
|
|
Psychosocial health
|
51.70
|
62.90
|
52.40 (17.22)
|
62.20 (18.91)
|
8.30 (16.10%)
|
2.25*
|
0.58
|
|
VAS
|
|
Hyperactivity/impulsivity
|
6.70
|
3.50
|
5.90 (2.43)
|
3.60 (2.49)
|
− 1.70 (− 44.60%)
|
− 4.77***
|
1.10
|
|
Tantrum/mood lability
|
5.40
|
2.90
|
4.70 (2.09)
|
3.20 (2.18)
|
− 1.00 (− 33.90%)
|
− 3.59**
|
0.86
|
|
Anxiety
|
6.50
|
3.80
|
6.00 (2.05)
|
3.80 (1.93)
|
− 2.20 (− 35.40%)
|
− 4.25***
|
1.01
|
|
CGI
|
|
CGI-S
|
5.00
|
–
|
5.10 (1.39)
|
–
|
–
|
–
|
–
|
|
CGI-I
|
–
|
2.00
|
–
|
2.50 (1.01)
|
–
|
–
|
–
|
- Note. Prior to tabulation change in score at week 12 was calculated for each subject by (change = score at week 12 − score at screening), and percent change in score at week 12 was calculated for each subject by [% Change = 100 × (change at week 12/score at screening)]
- *p<.05 compared to screening
- **p<.01 compared to screening
- ***p<.001 compared to screening
