Table 2.
Primary and secondary analyses, change from baseline to 2-hour timepoint (LOCF)
| |
IM Olz, 10 mg (N=45) |
IM Placebo (N=44) |
p valueb |
||||
|---|---|---|---|---|---|---|---|
| Mean (points) | SD | 95%CI | Mean (points) | SD | 95%CI | ||
| Baseline |
|
|
|
|
|
|
|
| PANSS-EC total |
23.5 |
6.1 |
21.7, 25.4 |
23.3 |
4.9 |
21.8, 24.8 |
.638 |
| Poor impulse control |
4.8 |
1.2 |
4.5, 5.2 |
4.7 |
1.2 |
4.3, 5.0 |
.336 |
| Tension |
4.7 |
1.6 |
4.2, 5.2 |
4.7 |
1.1 |
4.3, 5.0 |
.722 |
| Hostility |
4.6 |
1.6 |
4.1, 5.1 |
4.6 |
1.3 |
4.2, 5.0 |
.912 |
| Uncooperativeness |
4.7 |
1.3 |
4.3, 5.1 |
4.8 |
1.2 |
4.4, 5.1 |
.791 |
| Excitement |
4.7 |
1.2 |
4.4, 5.1 |
4.6 |
1.0 |
4.3, 4.9 |
.385 |
| ACESa |
1.6 |
0.5 |
1.5, 1.7 |
1.6 |
0.5 |
1.5,1.8 |
.741 |
| 2 hours |
|
|
|
|
|
|
|
| PANSS-EC total |
14.3 |
6.0 |
12.5, 16.1 |
20.5 |
7.5 |
18.3, 22.8 |
|
| Poor impulse control |
3.0 |
1.3 |
2.6, 3.4 |
4.1 |
1.5 |
3.7, 4.6 |
|
| Tension |
2.9 |
1.2 |
2.5, 3.2 |
4.1 |
1.7 |
3.6, 4.6 |
|
| Hostility |
2.8 |
1.3 |
2.4, 3.1 |
4.0 |
1.7 |
3.5, 4.5 |
|
| Uncooperativeness |
2.9 |
1.4 |
2.5, 3.3 |
4.3 |
1.6 |
3.8, 4.8 |
|
| Excitement |
2.8 |
1.2 |
2.4, 3.2 |
4.0 |
1.5 |
3.5, 4.4 |
|
| ACES |
3.5 |
1.7 |
2.9, 4.0 |
2.2 |
1.3 |
1.8, 2.6 |
|
| Change, baseline-2 hours |
|
|
|
|
|
|
|
| PANSS-EC Total |
−9.2 |
4.5 |
−10.6, -7.9 |
−2.8 |
5.6 |
−4.5, -1.1 |
<.001 |
| Poor impulse control |
−1.9 |
1.0 |
−2.2, -1.6 |
−0.6 |
1.2 |
−0.9, -0.2 |
<.001 |
| Tension |
−1.8 |
1.1 |
−2.2, -1.5 |
−0.6 |
1.1 |
−0.9, -0.2 |
<.001 |
| Hostility |
−1.8 |
1.2 |
−2.2, -1.5 |
−0.6 |
1.5 |
−1.0, -0.1 |
<.001 |
| Uncooperativeness |
−1.7 |
0.9 |
−2.0, -1.5 |
−0.5 |
1.2 |
−0.8, -0.1 |
<.001 |
| Excitement |
−1.9 |
1.1 |
−2.3, -1.6 |
−0.6 |
1.4 |
−1.0, -0.2 |
<.001 |
| ACES | 1.9 | 1.5 | 1.4, 2.3 | 0.6 | 1.1 | 0.2, 0.9 | <.001 |
Abbreviations: ACES=Agitation-Calmness Evaluation Scale; CI=confidence interval; IM Olz=intramuscular olanzapine; LOCF=last observation carried forward [analysis]; N=number of patients with a baseline and a value at the time (LOCF); PANSS-EC=Positive and Negative Syndrome Scale-Excited Component.
aAt baseline placebo n=45.
bp value: ANOVA model which includes Treatment and Site as factors.