Table 6.
Mean Change from Double-Blind Baseline to Open-Label End-Point in Clinical Global Impressions-Severity Scale, Children's Yale-Brown Obsessive Compulsive Scale, and Aberrant Behavior Checklist Subscales (Open-Label Analysis Set)
| Placebo/RIS group (n=30) | RIS low-dose/RIS group (n=24) | RIS high-dose/RIS group (n=25) | |
|---|---|---|---|
| Clinical Global Impressions-Severity | |||
| Mean (SD) baseline |
4.9 (0.67) |
5.1 (0.93) |
5.0 (0.75) |
| Mean change (SD) |
−0.9 (0.88) |
−1.0 (1.02) |
−1.3 (1.17) |
| Compulsions total score | |||
| Mean (SD) baseline |
13.7 (2.66) |
13.4 (3.99) |
14.4 (4.64) |
| Mean change (SD) |
−5.3 (4.99) |
−4.1 (3.01) |
−5.6 (4.66) |
| Aberrant Behavior Checklist Subscales | |||
| Irritability | |||
| Mean (SD) baseline |
28.4 (6.03) |
27.8 (6.58) |
28.8 (8.24) |
| Mean change (SD) |
−11.8 (7.68) |
−13.2 (9.29) |
−13.0 (10.55) |
| Lethargy/social withdrawal | |||
| Mean (SD) baseline |
18.1 (10.16) |
18.2 (9.71) |
21.4 (9.09) |
| Mean change (SD) |
−6.9 (8.08) |
−8.3 (9.03) |
−10.4 (8.57) |
| Stereotyped behavior | |||
| Mean (SD) baseline |
10.5 (5.26) |
9.3 (5.17) |
11.5 (5.06) |
| Mean change (SD) |
−2.8 (4.12) |
−4.2 (6.51) |
−4.6 (5.14) |
| Hyperactivity | |||
| Mean (SD) baseline |
31.4 (8.60) |
30.1 (11.46) |
33.8 (9.75) |
| Mean change (SD) |
−11.7 (8.54) |
−10.5 (12.42) |
−12.3 (11.78) |
| Inappropriate speech | |||
| Mean (SD) baseline |
5.9 (3.42) |
6.6 (3.49) |
7.5 (2.78) |
| Mean change (SD) | −1.5 (2.69) | −1.8 (3.93) | −2.1 (3.07) |
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.