Primary outcome
|
Clinical Global Impression-Improvement
|
52
|
–
|
–
|
3.4
|
0.13
|
54
|
–
|
–
|
3.5
|
0.13
|
0.45
|
Key secondary outcome
|
Pediatric Anxiety Rating Scale (total score)
|
55
|
10.5
|
0.76
|
8.3
|
0.54
|
55
|
10.9
|
0.73
|
9.2
|
0.54
|
0.22
|
Other secondary outcome
|
Visual Analogue Scale
|
Severity of Anxiety (cm)
|
55
|
4.3
|
0.37
|
5.6
|
0.27
|
54
|
4.2
|
0.34
|
5.0
|
0.26
|
0.13
|
Severity of attention (cm)
|
55
|
3.4
|
0.30
|
4.4
|
0.24
|
54
|
3.3
|
0.31
|
3.9
|
0.24
|
0.14
|
Severity of one selected additional target behavior (sociability, language, aggression, hyperactivity/impulsivity) (cm)
|
55
|
3.2
|
0.30
|
4.4
|
0.28
|
54
|
3.3
|
0.33
|
3.9
|
0.27
|
0.25
|
Anxiety, Depression and Mood Scale
|
Manic/hyperactive behavior total
|
54
|
8.1
|
0.51
|
7.4
|
0.42
|
53
|
8.7
|
0.50
|
7.8
|
0.40
|
0.49
|
Depressed mood total
|
55
|
3.0
|
0.46
|
3.5
|
0.32
|
54
|
3.1
|
0.42
|
2.6
|
0.32
|
0.01
|
Social avoidance total
|
55
|
6.9
|
0.60
|
5.8
|
0.42
|
54
|
7.5
|
0.62
|
6.3
|
0.41
|
0.39
|
General anxiety total
|
55
|
7.9
|
0.62
|
6.2
|
0.45
|
54
|
8.3
|
0.60
|
7.0
|
0.44
|
0.21
|
Obsessive/compulsive behavior total
|
55
|
3.0
|
0.32
|
2.7
|
0.21
|
54
|
3.4
|
0.31
|
2.8
|
0.20
|
0.81
|
Aberrant Behavior Checklist-Community Edition FXS algorithm (ABC-CFX)
|
Total - subscale I (irritability)
|
55
|
18.9
|
1.53
|
15.7
|
0.87
|
54
|
19.6
|
1.51
|
16.1
|
0.86
|
0.62
|
Total - subscale II (lethargy)
|
55
|
6.6
|
0.68
|
5.6
|
0.53
|
52
|
6.9
|
0.68
|
5.7
|
0.54
|
0.74
|
Total - subscale III (stereotypy)
|
55
|
7.4
|
0.68
|
5.7
|
0.40
|
54
|
7.1
|
0.68
|
6.4
|
0.39
|
0.17
|
Total - subscale IV (hyperactivity)
|
54
|
13.9
|
1.00
|
11.3
|
0.65
|
54
|
13.9
|
1.14
|
12.3
|
0.62
|
0.28
|
Total - subscale V (inappropriate speech)
|
55
|
6.0
|
0.47
|
5.1
|
0.32
|
54
|
6.3
|
0.43
|
5.3
|
0.31
|
0.47
|
Total - subscale VI (social avoidance)
|
55
|
3.5
|
0.43
|
2.4
|
0.22
|
54
|
3.1
|
0.40
|
2.8
|
0.21
|
0.25
|
Swanson, Nolan, and Pelham-IV Questionnaire
|
ADHD inattention total
|
53
|
15.7
|
0.76
|
15.5
|
0.66
|
53
|
16.7
|
0.79
|
14.6
|
0.62
|
0.28
|
ADHD inattention average
|
53
|
1.7
|
0.08
|
1.7
|
0.07
|
53
|
1.9
|
0.09
|
1.6
|
0.07
|
0.28
|
ADHD hyperactive impulsive total
|
54
|
13.0
|
0.93
|
13.9
|
0.66
|
53
|
14.0
|
0.92
|
12.6
|
0.64
|
0.12
|
ADHD hyperactive impulsive average
|
54
|
1.4
|
0.10
|
1.5
|
0.07
|
53
|
1.6
|
0.10
|
1.4
|
0.07
|
0.14
|
ADHD combined total
|
53
|
28.7
|
1.52
|
29.3
|
1.19
|
53
|
30.7
|
1.54
|
27.1
|
1.14
|
0.15
|
ADHD combined average
|
53
|
1.6
|
0.08
|
1.6
|
0.07
|
53
|
1.7
|
0.09
|
1.5
|
0.06
|
0.21
|