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Table 3 Baseline-to-endpoint change in itemized LS Mean MADRS scores

From: Efficacy and safety of olanzapine for treatment of patients with bipolar depression: Japanese subpopulation analysis of a randomized, double-blind, placebo-controlled study

 

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

 
  1. 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.
  2. 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).
  3. 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.
  4. 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.
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BMC Psychiatry

ISSN: 1471-244X

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