Table 5.
Mean Change from Double-Blind Baseline to Open-Label End-Point in Weight and Body Mass Index (Open-Label Safety Analysis Set)
| Placebo/RIS group (n=30) | RIS low-dose/RIS group (n=24) | RIS high-dose/RIS group (n=25) | |
|---|---|---|---|
| Weight (kg) | |||
| Mean (SD) baseline |
37.9 (18.00) |
40.3 (24.76) |
36.5 (15.86) |
| Mean change (SD) |
4.3 (3.25) |
4.7 (3.72) |
5.5 (2.86) |
| Weight Z score | |||
| Mean (SD) baseline |
0.90 (1.20) |
0.43(1.43) |
0.34 (1.27) |
| Mean change (SD) |
0.22 (0.330) |
0.36 (0.410) |
0.40 (0.340) |
| BMI(kg/m2) | |||
| Mean (SD)baseline |
19.5 (4.96) |
20.1 (5.82) |
18.8 (4.85) |
| Mean change (SD) |
1.1 (1.30) |
1.5 (1.76) |
2.0 (1.67) |
| BMI Z score | |||
| Mean baseline |
0.75 (1.32) |
0.78 (1.20) |
0.26 (2.11) |
| Mean change (SD) | 0.27 (0.424) | 0.25 (0.473) | 0.69 (1.643) |
BMI, body mass index; 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.