Enclosure 5
NDA 20-358
WELLBUTRIN SR (bupropion hydrochloride) Tablets
|
Table
4 Size of Treatment Effect
in Study 203 (Difference Between
Bupropion SR and Placebo in Mean Change from
Baseline for HAMD-17 Total Score at Week 8 (LOCF) |
|||
|
Groups |
Baseline1 |
Baseline-Wk82 |
Difference3 |
|
Placebo |
23.2 |
-8.1 |
|
|
Bup. SR 150 mg |
23.1 |
-10.2 |
2.1 |
|
Bup. SR 300 mg |
23.4 |
-10.2 |
2.1 |
|
Table
5 Size of Treatment Effect
in Study 205 (Difference Between
Bupropion SR and Placebo in Mean Change from
Baseline for HAMD-17 Total Score at Week 8 (LOCF) |
|||
|
Groups |
Baseline1 |
Baseline-Wk82 |
Difference3 |
|
Placebo |
23.4 |
-8.3 |
|
|
Bup. SR 100 mg |
23.6 |
-10.5 |
2.2 |
|
Bup. SR 200 mg |
23.2 |
-9.6 |
1.3 |
|
Bup. SR 300 mg |
23.6 |
-9.0 |
0.7 |
|
Bup. SR 400 mg |
24.2 |
-9.3 |
1.0 |
|
Table
6 Size of Treatment Effect
in Study 212 (Difference Between
Bupropion SR and Placebo in Mean Change from
Baseline for HAMD-17 Total Score at Week 8 (LOCF) |
|||
|
Groups |
Baseline1 |
Baseline-Wk82 |
Difference3 |
|
Placebo |
27.2 |
-11.2 |
|
|
Bup. SR 150 mg |
27.8 |
-14.0 |
2.8 |
|
Bup. Sr 300 mg |
28.2 |
-13.2 |
2.0 |
1
Baseline
mean HAMD Total Score
2
Change
from baseline to week 8 (LOCF)
3
Difference
between bupropion SR and placebo in mean change
from baseline to week 8
(LOCF) from HAMD Total Score
Back a Page
Next Section - Review and Evaluation of Clinical Data
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index