Table 4.
Treatment Outcomes
| Outcomes | Total (n=79) | Early responder (n=36) | Early nonresponder (n=43) | p value |
|---|---|---|---|---|
| All-cause discontinuation, n (%) |
19 (24.4) |
5 (13.9) |
14 (33.3) |
0.064 |
| Discontinuation, reasons,an (%) | ||||
| Inefficacy |
8 (10.4) |
1 (2.8) |
7 (17.1) |
0.061 |
| Intolerability |
9 (11.7) |
3 (8.3) |
6 (14.6) |
0.49 |
| Loss of contact |
4 (5.2) |
2 (5.6) |
2 (4.9) |
1.00 |
| Number of inpatient days (mean±SD) |
25.6±21.7 |
20.7±19.5 |
30.1±23.5 |
0.09 |
| Response (CGI-I</=2), n (%) |
45 (57.0) |
30 (83.3) |
15 (34.9) |
<0.0001 |
| CGI-I, mean±SD | ||||
| 4 weeks |
2.6±0.5 |
1.7±0.5 |
3.4±0.5 |
<0.0001 |
| 8 weeks |
2.4±0.9 |
1.8±1.0 |
3.0±0.7 |
<0.0001 |
| 12 weeks |
2.1±0.8 |
1.5±0.7 |
2.7±0.9 |
<0.0001 |
| CGI-S change, mean±SD | ||||
| 4 weeks |
−1.2±0.8 |
−1.9±1.0 |
−0.6±0.7 |
<0.0001 |
| 8 weeks |
−1.4±1.0 |
−2.0±1.2 |
−0.8±0.8 |
<0.0001 |
| 12 weeks |
−1.7±1.2 |
−2.4±1.4 |
−1.2±1.1 |
<0.0001 |
| CGAS change, mean±SD | ||||
| 4 weeks |
11.9±7.3 |
18.1±8.3 |
6.7±6.4 |
<0.0001 |
| 8 weeks |
15.2±9.4 |
20.6±9.7 |
10.6±9.1 |
<0.0001 |
| 12 weeks |
18.0±11.0 |
23.5±11.2 |
13.0±10.8 |
<0.0001 |
| EPS, n (%) | ||||
| 4 weeks |
15 (21.4) |
2 (6.1) |
13 (35.1) |
0.0035 |
| 8 weeks |
14 (19.7) |
2 (6.1) |
12 (31.6) |
0.0079 |
| 12 weeks |
14 (19.4) |
1 (3.0) |
13 (33.3) |
0.0019 |
| Anytime at 4, 8 or 12 weeks |
22 (30.6) |
4 (12.2) |
18 (46.2) |
0.0018 |
| Akathisia, n (%) | ||||
| 4 weeks |
5 (6.6) |
2 (5.7) |
3 (7.3) |
1.00 |
| 8 weeks |
5 (6.5) |
1 (2.9) |
4 (9.5) |
0.37 |
| 12 weeks |
4 (5.2) |
1 (2.9) |
3 (7.1) |
0.62 |
| Anytime at 4, 8 or 12 weeks |
6 (7.8) |
2 (5.7) |
4 (9.5) |
0.53 |
| Weight change, kg, mean±SD | ||||
| 4 weeks |
3.1±2.6 |
3.0±2.1 |
3.3±3.0 |
0.64 |
| 8 weeks |
4.8±3.7 |
4.9±3.0 |
4.8±4.2 |
0.92 |
| 12 weeks |
5.7±4.3 |
5.5±3.5 |
5.9±4.9 |
0.65 |
| Weight % change, mean±SD, 12 weeks |
11.0±8.8 |
10.4±7.0 |
11.6±10.2 |
0.56 |
| Weight gain ≥7%, n (%), 12 weeks |
51 (64.5) |
24 (66.7) |
27 (62.8) |
0.72 |
| BMI change, kg/m3, mean±SD | ||||
| 4 weeks |
1.1±0.9 |
1.1±0.8 |
1.1±1.1 |
0.91 |
| 8 weeks |
1.7±1.3 |
1.7±1.1 |
1.6±1.4 |
0.75 |
| 12 weeks |
1.9±1.5 |
1.9±1.3 |
2.0±1.7 |
0.73 |
| BMI z-score change, mean±SD | ||||
| 4 weeks |
0.4±0.4 |
0.4±0.4 |
0.4±0.4 |
0.96 |
| 8 weeks |
0.7±1.0 |
0.8±0.9 |
0.6±1.0 |
0.23 |
| 12 weeks | 0.6±0.6 | 0.6±0.5 | 0.6±0.7 | 0.83 |
a
Total may be >100% of all-cause discontinuation because of discontinuation for more than one reason.
BMI, body mass index; CGAS, Children's Global Assessment of Functioning Scale; CGI-I, Clinical Global Impressions- Improvement; CGI-S, Clinical Global Impressions-Severity; EPS, Extrapyramidal Side Effects.
Bolded p-values indicate p<0.05.