TABLE 4.
Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and Abnormal Involuntary Movement Scale (AIMS) Scores at Baseline and Endpoint in Phases 1, 2, and 3
Phases 1 and 2: Open-Label (%) |
Phase 3: Double-Blind (%) |
|||
---|---|---|---|---|
Citalopram Monotherapy |
Risperidone Augmentation |
Risperidone Augmentation |
Placebo Augmentation |
|
N | 110 | 93 | 31 | 32 |
SAS | ||||
Baseline | 1.2 ± 2.7 | 0.7 ± 1.3 | 0.7 ± 1.4 | 0.1 ± 0.4 |
Endpoint | 0.7 ± 1.3 | 0.6 ± 1.3 | 0.6 ± 1.2 | 0.1 ± 0.3 |
t value (df) | −2.36 (df = 106) | −1.40 (df = 92) | −0.57 (df = 28) | −0.70 (df = 28) |
p value | 0.0201 | 0.1649 | 0.5728 | 0.4892 |
BAS | ||||
Baseline | 0.3 ± 0.8 | 0.2 ± 0.6 | 0.1 ± 0.4 | 0.1 ± 0.3 |
Endpoint | 0.2 ± 0.6 | 0.3 ± 0.8 | 0.1 ± 0.4 | 0.1 ± 0.4 |
t value (df) | −1.27 (df = 106) | 0.33 (df = 92) | −0.33 (df = 28) | −0.57 (df = 28) |
p value | 0.2074 | 0.7439 | 0.7452 | 0.5728 |
AIMS | ||||
Baseline | 0.7 ± 2.4 | 0.7 ± 2.8 | 0.6 ± 2.0 | 0.4 ± 1.8 |
Endpoint | 0.7 ± 2.6 | 0.5 ± 1.8 | 0.3 ± 1.3 | 0.1 ± 0.4 |
t value (df) | 0.19 (df = 106) | −1.37 (df = 92) | −1.00 (df = 28) | −0.87 (df = 28) |
p value | 0.8520 | 0.1737 | 0.3259 | 0.3892 |
Notes: Data are means ± SD. p Values were calculated from a paired t-test to determine whether the mean change from baseline differs from zero.