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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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