Therapies for Children With Autism Spectrum Disorders

Table 17. Outcomes of RCTs of antipsychotic medications for challenging and repetitive
behaviors (continued)
Author, year, country
Groups, N enrollment / N
final
Study quality
Owen et al. 216
2009, US
G1: aripiprazole, 47/39
G2: placebo, 51/36
Quality: Good
Mean age, years
± SD
G1: 9.7 ± 3.2
G2:
8.8 ± 2.6
Mean IQ ±SD Outcome
measure/Baseline
scores, mean ±SD
NR ABC-C-Irritability: G1:
29.6 ± 6.4
G2: 30.2 ± 6.5
ABC-C-Hyperactivity/
Noncompliance: G1:
34.1
G2: 34.7
ABC-C-Stereotypic:
G1: 11.9
G2: 10.7
CYBOCS:
G1: 12.8
G2: 13.7
65
Outcome
measure/Posttreatment
scores a ,
mean ± SD
Change in:
ABC-Irritability
(change):
G1: -12.9
G2: -5.0
P< 0.001
ABC-C-Hyperactivity/
Noncompliance
(change):
G1: -12.7
G2: -2.8
P< 0.001
ABC-C-Stereotypic
(change):
G1: -4.8
G2: -2.0
p< 0.001
CYBOCS (change):
G1: -3.8
G2: -0.8
p< 0.001
CYBOCS (change):
G1: -3.8
G2: -0.8
p< 0.001
a Decrease in scores on outcome measures indicates improvement in behavior assessed. ABC-C=Aberrant Behavior Checklist-
Community Version; CGI-I=Clinical Global Impression-Irritability; CYBOCS=Children’s Yale-Brown Obsessive Compulsive
Scale; NR=not reported; RUPP=Research Units on Pediatric Psychopharmacology
Case series data, including that from the risperidone arm and open label extension of the
RUPP RCT, 203 indicated results consistent with the risperidone arms of the RCTs. 177,203,206,208,214
Aripiprazole. We identified two eight-week randomized, controlled trials of aripiprazole in
children with ASDs (Table 17). 215,216 The manufacturer of aripiprazole sponsored both studies.
The primary outcome for these studies was challenging behavior indexed by the ABC-C
Irritability subscale. These studies included a total of 213 subjects in aripiprazole arms and 103
subjects in placebo arms within the intent to treat analyses.
One study used a fixed dose design with one placebo arm and three arms corresponding to 5,
10, and 15 mg per day of aripiprazole, 215 with all subjects beginning at two mg per day with
forced titration weekly to the next dose until they reached their goal dose. The other study used a
dose titration schedule with weekly progression from 2 mg to 5 mg, 10 mg, and 15 mg per day
following clinical judgment. 216 In these two studies, baseline ratings of irritability were similar
across aripiprazole (ABC-C-I 28.2-29.6) and placebo (ABC-C-Irritability 28.0-30.8) arms.
Decreases in ABC-C Irritability were significantly greater for the aripiprazole arms in both
studies, with improvements of 12.4-14.4, in comparison to the placebo arms, with improvements
of 5.0-8.4. The trial with differing set doses of aripiprazole demonstrated increasing response
with increasing dose. 215 Overall, the results of the trial that used titration following clinical
judgment were more pronounced. 216