Table 4.
Change in Positive and Negative Syndrome Scale (PANSS) scores in acute mania aripiprazole randomised controlled trials (RCTs)
| Trial | 3 weeks | 12 weeks | N (efficacy sample) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| PANSS-total | PANSS-positive | PANSS-negative | PANSS-cognitive | PANSS-hostility | PANSS-total | PANSS-positive | PANSS-negative | PANSS-cognitive | PANSS-hostility | ||
| Aripiprazole | |||||||||||
| CN138-009 | - | - | - | - | - | 125 | |||||
| CN138-074 | -10.0 ± 18.2 | - | - | - | - | 136 | |||||
| CN138-135 | -9.5 ± 17.4 | - | - | -2.0 ± 4.6 | -2.1 ± 4.6 | -10.6 ± 19.4 | - | - | -2.9 ± 5.7 | -2.5 ± 4.6 | 154 |
| CN138-162 | -8.2 ± 12.9 | -3.8 ± 5.1 | -0.4 ± 2.6 | -2.4 ± 3.9 | -2.3 ± 3.9 | -9.8 ± 14.2 | -4.9 ± 5.2 | -0.2 ± 2.6 | -3.2 ± 5.2 | -3.0 ± 3.9 | 152 |
| CN138-007 | -2 ± -a | - | - | - | - | 267 - | |||||
| CN138-008 | - | - | - | - | - | - | - | - | - | - | 171 |
| Pooled mean | -6.5 | -3.8 | -0.4 | -2.2 | -2.2 | -10.2 | -4.9 | -0.2 | -3.0 | -2.7 | 1,005 |
| Pooled SD | 16.3 | 5.1 | 2.6 | 4.3 | 4.3 | 16.9 | 5.2 | 2.6 | 5.5 | 4.3 | |
| Placebo | |||||||||||
| CN138-009 | - | - | - | - | - | 123 | |||||
| CN138-074 | -5.3 ± 17.9 | - | - | - | - | 132 | |||||
| CN138-135 | -4.9 ± 16.7 | - | - | -0.9 ± 4.8 | -1.0 ± 3.6 | 163 | |||||
| CN138-162 | -4.7 ± 12.4 | -2.4 ± 4.9 | -0.1 ± 2.5 | -1.5 ± 6.2 | -1.2 ± 6.2 | 152 | |||||
| CN138-007 | -2.3 ± -a | - | - | - | - | 134 - | |||||
| CN138-008 | |||||||||||
| Pooled mean | -4.3 | -2.4 | -0.1 | -1.2 | -1.1 | 704 | |||||
| Pooled SD | 15.8 | 4.9 | 2.5 | 5.5 | 5.0 | ||||||
| Comparator | |||||||||||
| CN138-009 | |||||||||||
| CN138-074 | |||||||||||
| CN138-135 | -7 ± 17.7 | - | - | -1.6 ± 4.7 | -1.6 ± 3.5 | -7.4 ± 18.8 | - | - | -2.0 ± 4.7 | -1.8 ± 4.7 | 155 |
| CN138-162 | -8.8 ± 12.8 | -4.2 ± 5.1 | -0.3 ± 2.6 | -2.5 ± 3.9 | -2.6 ± 3.9 | -11.7 ± 14.1 | -5.4 ± 5.1 | -0.3 ± 2.6 | -3.9 ± 5.1 | -3.5 ± 3.9 | 161 |
| CN138-007 | |||||||||||
| CN138-008 | - | - | - | - | - | - | - | - | - | - | 158 |
| Pooled mean | -7.9 | -4.2 | -0.3 | -2.0 | -2.1 | -9.6 | -5.4 | -0.3 | -3 | -2.7 | 474 |
| Pooled SD | 15.4 | 5.1 | 2.6 | 4.3 | 3.7 | 16.6 | 5.1 | 2.6 | 4.9 | 4.3 | |
Dash indicates missing data.
aNot included in the calculation of the pooled measures because of a different study design (fixed dosage).