Table 1.
Pretreatment Baseline Characteristics of Patients Entering Open-Label Extension Phase (Intent-to-Treat Analysis Set)
| Parameters | Placebo/RIS (n=30) n (%) | RIS low-dose/RIS (n=24) n (%) | RIS high-dose/RIS (n=25) n (%) | Total (n=79) |
|---|---|---|---|---|
| Age (years) Category | ||||
| 0–<12 |
27 (90) |
17 (71) |
20 (80) |
64 (81) |
| >12 |
3 (10) |
7 (29) |
5 (20) |
15 (19) |
| Mean (SD) |
8.5 (2.53) |
10 (3.7) |
9.2 (2.82) |
9.2 (3.1) |
| Sex | ||||
| Boys |
26 (87) |
21 (88) |
23 (92) |
70 (89) |
| Girls |
4 (13) |
3 (13) |
2 (8) |
9 (11) |
| Race | ||||
| White |
18 (60) |
16 (67) |
21 (84) |
55 (70) |
| Black |
9 (30) |
5 (21) |
2 (8) |
16 (20) |
| Asian |
0 |
1 (4) |
0 |
1 (1) |
| Other |
1 (3) |
1 (4) |
2 (8) |
4 (5) |
| Baseline body mass index (kg/m2) | ||||
| Mean (SD) |
19.5 (4.87) |
20.4 (5.64) |
18.7 (4.74) |
19.5 (5.05) |
| Age at first diagnosis of autism | ||||
| Mean (SD) |
4.7 (2.75) |
5.0 (3.07) |
3.8 (1.89) |
4.5 (2.63) |
| Mental age (years) | ||||
| Mean (SD) |
5.6 (2.60) |
6.4 (3.31) |
6.2 (3.40) |
6.0 (3.07) |
| Previous antipsychotic use | ||||
| Yes |
2 (7) |
3 (13) |
2 (8) |
7 (9) |
| No | 28 (93) | 21 (88) | 23 (92) | 72 (91) |
RIS, risperidone; placebo/RIS, patients randomly assigned to placebo during double-blind (DB) phase who continued into open-label extension (OLE) and received risperidone; RIS low dose/RIS, patients randomly assigned to risperidone low dose during DB phase who continued into OLE and received risperidone; RIS high dose/RIS, patients randomly assigned to risperidone high dose during DB phase who continued into OLE and received risperidone.