| |
LOCF analysis
|
MMRM analysis
|
|---|
| |
Baseline
|
Endpoint
|
p Valuea
|
Endpoint
|
p Valueb
|
|---|
|
MADRS Item
|
Tx
|
N
|
Mean
|
LS Mean
|
Within Tx
|
Between Tx
|
N
|
LS Mean
|
Within Tx
|
Between Tx
|
|---|
| | | |
(SD)
|
Change
| | | |
Change
| | |
|---|
| | | | |
(SE)
| | | |
(SE)
| | |
|---|
|
Apparent Sadness
|
PBO
|
52
|
3.12 (1.06)
|
−1.42 (0.19)
|
<.001
|
.36
|
43
|
−1.47 (0.19)
|
<.001
|
.16
|
| |
OLZ
|
104
|
3.23 (1.10)
|
−1.63 (0.13)
|
<.001
| |
87
|
−1.80 (0.13)
|
<.001
| |
|
Reported Sadness
|
PBO
|
52
|
3.35 (1.23)
|
−1.56 (0.20)
|
<.001
|
.10
|
43
|
−1.60 (0.21)
|
<.001
|
.03
|
| |
OLZ
|
104
|
3.57 (1.06)
|
−1.95 (0.14)
|
<.001
| |
87
|
−2.15 (0.15)
|
<.001
| |
|
Inner Tension
|
PBO
|
52
|
2.71 (1.23)
|
−0.73 (0.16)
|
<.001
|
<.001
|
43
|
−0.78 (0.16)
|
<.001
|
<.001
|
| |
OLZ
|
104
|
2.70 (1.09)
|
−1.43 (0.11)
|
<.001
| |
87
|
−1.53 (0.12)
|
<.001
| |
|
Reduced Sleep
|
PBO
|
52
|
3.02 (1.63)
|
−0.75 (0.22)
|
<.001
|
<.001
|
43
|
−1.01 (0.22)
|
<.001
|
.001
|
| |
OLZ
|
104
|
2.88 (1.63)
|
−1.83 (0.15)
|
<.001
| |
87
|
−1.91 (0.16)
|
<.001
| |
|
Reduced Appetite
|
PBO
|
52
|
1.79 (1.70)
|
−0.78 (0.16)
|
<.001
|
.003
|
43
|
−0.91 (0.16)
|
<.001
|
.004
|
| |
OLZ
|
104
|
1.77 (1.52)
|
−1.35 (0.11)
|
<.001
| |
87
|
−1.51 (0.12)
|
<.001
| |
|
Concentration Difficulties
|
PBO
|
52
|
3.65 (1.23)
|
−1.30 (0.21)
|
<.001
|
.75
|
43
|
−1.46 (0.22)
|
<.001
|
.78
|
| |
OLZ
|
104
|
3.67 (1.08)
|
−1.38 (0.15)
|
<.001
| |
87
|
−1.53 (0.16)
|
<.001
| |
|
Lassitude
|
PBO
|
52
|
3.10 (1.09)
|
−1.22 (0.19)
|
<.001
|
.32
|
43
|
−1.33 (0.20)
|
<.001
|
.37
|
| |
OLZ
|
104
|
3.23 (1.10)
|
−1.45 (0.13)
|
<.001
| |
87
|
−1.56 (0.14)
|
<.001
| |
|
Inability to Feel
|
PBO
|
52
|
3.29 (1.18)
|
−1.20 (0.20)
|
<.001
|
.06
|
43
|
−1.24 (0.22)
|
<.001
|
.03
|
| |
OLZ
|
104
|
3.43 (0.91)
|
−1.66 (0.14)
|
<.001
| |
87
|
−1.82 (0.15)
|
<.001
| |
|
Pessimistic Thoughts
|
PBO
|
52
|
3.08 (1.08)
|
−1.05 (0.19)
|
<.001
|
.03
|
43
|
−1.04 (0.20)
|
<.001
|
.01
|
| |
OLZ
|
104
|
3.10 (1.02)
|
−1.54 (0.13)
|
<.001
| |
87
|
−1.66 (0.14)
|
<.001
| |
|
Suicidal Thoughts
|
PBO
|
52
|
1.52 (1.0)
|
−0.68 (0.13)
|
<.001
|
.87
|
43
|
−0.80 (0.13)
|
<.001
|
.95
|
| |
OLZ
|
104
|
1.41 (0.82)
|
−0.71 (0.09)
|
<.001
| |
87
|
−0.79 (0.09)
|
<.001
| |
|
MADRS-6c Subscale
|
PBO
|
52
|
18.63 (5.02)
|
−7.16 (0.94)
|
<.001
|
.03
|
43
|
−7.25 (0.99)
|
<.001
|
.008
|
| |
OLZ
|
104
|
19.26 (3.88)
|
−9.67 (0.66)
|
<.001
| |
87
|
−10.54 (0.70)
|
<.001
| |
- Abbreviations: LOCF = last observation carried forward; LS mean = least squares mean; MADRS = Montgomery-Åsberg Depression Rating Scale; MMRM = mixed-effects model repeated measures; OLZ = olanzapine group; PBO = placebo group; SD = standard deviation; SE = standard error.
-
a within treatment p values are from t-tests on LS Mean change; p values and LS Mean for change from baseline are from analysis of covariance model: change = treatment + baseline + geographic region (Type III sums of squares).
-
b within treatment p values are from t-tests on LS Mean change; p values are from Type III sums of squares and Kenward-Roger approximation as denominator degrees of freedom; MMRM analysis: change = treatment + baseline + geographic region + visit + treatment * visit.
-
c MADRS-6 subscale contains 6 individual MADRS items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts, considered to be “core” depressive symptoms.
