However, the difference in change of the PANSS total in the PP
population was 3.98 points (p = 0.0566). This is close to significant.
Other comparisons showed weaker but consistent trends in favor of risperidone
on efficacy. For example, CGI were near significant. In the FAS
sample, 18.7% of patients were normal or borderline ill on aripiprazole
at endpoint compared with 32.1% on risperidone. 21.6% of aripiprazole
patients were still markedly ill at the end of the study, vs. only 11.4% on
risperidone. These seem numerically important though p was 0.0839. In
the PP sample, 21.2% were very much improved on aripiprazole vs
35.3% on risperidone, and this time p = 0.0351. These data implicated
that there may be better efficacy with risperidone over aripiprazole for
overall improvement. However, a recent meta-analysis article found
that there were no significant differences on global state (n = 6381,
80 RCTs, low quality evidence) between aripiprazole and risperidone
Table 7
Incidence of treatment-emergent adverse events occurring in ≥5% of subjects in both
treatment groups (safety sample).
Adverse event,
n (%)
Aripiprazole
(n = 139)
Risperidone
(n = 140)
p value
Any adverse event 105 (76) 116 (83) 0.1321
Nervous system 90 (65) 86 (61) 0.566
Insomnia 36 (26) 33 (24) 0.652
Extrapyramidal syndrome 35 (25) 34 (24) 0.757
Akathisia 32 (23) 31 (22) 0.753
Tremor 7 (5) 3 (2) 0.194
Hypertonia 3 (2) 8 (6) 0.127
Digestive system 29 (21) 31 (22) 0.795
Constipation 20 (14) 20 (14) 0.981
Endocrine system 5 (4) 31 (22) b0.001
Hyperprolactinemia 5 (4) 30 (21) b0.001
Respiratory system 13 (9) 29 (21) 0.008
Upper respiratory infection 12 (9) 27 (19) 0.01
Cardiovascular system 11 (8) 9 (6) 0.631
Other 6 (4) 8 (6) 0.593
Asthenia 3 (2) 7 (5) 0.498
Abnormal liver function 5 (4) 8 (6) 0.402
A) Simpson-Angus scores
0
0.2
0.4
0.6
0.8
1w 2w 4w 6w
Mean (SD) change from baseline
Aripirazole
Risperidone
B) Barnes Rating Scale scores
0
0.3
0.6
0.9
1.2
1w 2w 4w 6w
Mean (SD) change from baseline
Aripiprazole
Risperidone
Fig. 3. Mean change from baseline of Simpson–Angus scores and Barnes Rating Scale scores over 6 weeks of the treatment with aripiprazole and risperidone. A: Simpson–Angus scores;
B: Barnes Rating Scale scores. The data were expressed as mean ± SD (Standard Deviation). No statistically significant differences were found between the two groups over 6 weeks. p N 0.05.
H. Li et al. / Schizophrenia Research 157 (2014) 112–119 117
(Khanna et al., 2014). So it is necessary to design a further study with a
larger sample to demonstrate the conclusion