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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