Skip to main content

Table 2 Primary and secondary analyses, change from baseline to 2-hour timepoint (LOCF)

From: A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation

 

IM Olz, 10 mg (N=45)

IM Placebo (N=44)

pvalueb

 

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

  1. 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.
  2. aAt baseline placebo n=45.
  3. b p value: ANOVA model which includes Treatment and Site as factors.