Table
AD8 Study 212 Mean
(X) and Mean Change (∆) from Baseline in MADRS Total Score |
||||||||||||||||||
LAST OBSERVATION CARRIED
FORWARD ANALYSIS |
||||||||||||||||||
Treatment Groups |
Treatment Week |
|||||||||||||||||
Baseline |
Wk 1 |
Wk 2 |
Wk 3 |
Wk 4 |
Wk 5 |
Wk 6 |
Wk 7 |
Wk 8 |
||||||||||
N |
X |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
|
BUP SR 150 (L) |
146 |
27.8 |
145 |
-4.3 |
146 |
-7.4 |
146 |
-9.3 |
146 |
-10.4 |
146 |
-11.8 |
146 |
-13.4 |
146 |
13.9 |
146 |
-14.0 |
BUP SR 300 (II) |
144 |
28.2 |
144 |
-3.2 |
144 |
-5.0 |
144 |
-8.2 |
144 |
-10.8 |
144 |
-11.1 |
144 |
-11.2 |
144 |
-12.6 |
144 |
-13.2 |
Placebo (P) |
148 |
27.2 |
145 |
-3.2 |
148 |
-6.0 |
148 |
-8.6 |
148 |
-9.4 |
148 |
-10.4 |
148 |
-11.0 |
148 |
-11.1 |
148 |
-11.2 |
2-sided p-values for
pairwise comparisons |
||||||||||||||||||
L vs P |
> 0.3 |
0.07 |
0.08 |
050 |
0.34 |
0.20 |
0.03 |
0.01 |
0.02 |
|||||||||
II vs P |
> 0.1 |
0.88 |
0.17 |
0.54 |
0.16 |
0.56 |
0.88 |
0.21 |
0.11 |
|||||||||
OBSERVED CASES ANALYSIS |
||||||||||||||||||
Treatment Groups |
Treatment Week |
|||||||||||||||||
Baseline |
Wk 1 |
Wk 2 |
Wk 3 |
Wk 4 |
Wk 5 |
Wk 6 |
Wk 7 |
Wk 8 |
||||||||||
N |
X |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
N |
∆ |
|
BUP SR 150 (L) |
146 |
27.8 |
145 |
-4.3 |
136 |
-7.5 |
133 |
-9.4 |
133 |
-10.8 |
12 |
-12.5 |
118 |
-14.8 |
117 |
-15.6 |
110 |
-16.2 |
BUP SR 300 (II) |
144 |
28.2 |
144 |
-3.2 |
136 |
-5.1 |
131 |
-9.0 |
121 |
-12.3 |
111 |
-13.0 |
104 |
-13.6 |
104 |
-15.6 |
101 |
-16.3 |
Placebo (P) |
148 |
27.2 |
145 |
-3.2 |
140 |
-6.1 |
132 |
-9.0 |
124 |
-10.0 |
117 |
-11.6 |
144 |
-12.8 |
107 |
-13.2 |
100 |
-13.5 |
2-sided p-values for pairwise
comparisons |
||||||||||||||||||
L vs P |
> 0.3 |
0.07 |
0.10 |
0.86 |
0.67 |
0.52 |
0.17 |
0.09 |
0.05 |
|||||||||
II vs P |
> 0.1 |
0.88 |
0.18 |
0.80 |
006 |
0.42 |
0.76 |
0.12 |
0.06 |
Bupropion SR Clinical Review Addendum for Protocol
212 22
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