|
NDA 20-358 |
Page 4 |
Impression: We consider
this to be a negative study that cannot provide support for the antidepressant
efficacy of either the 150 or 300 mg/day bupropion SR doses.
Study 205
(1)
Unadjusted
Results
The results in Table 2 were unadjusted for multiple comparisons, and even without such adjustment, these data did not suggest a consistent superiority for bupropion SR, at any of the 4 doses, over placebo.
The results were strongest
for the 100 mg/day dose group, in particular for HAMD-28 total score and CGI
Severity, but only for the LOCF analyses.
There were virtually no positive findings for the OC analyses for the
100 mg/day dose group, and no consistently positive findings for either LOCF or
OC analyses for any of the other higher dose groups.
(2)
Adjusted
Results
Given the four dose groups in this study, it was necessary to make an adjustment for multiple comparisons. One approach was to use Dunnett’s test, which yielded a critical p-value of 0.012 for declaring any particular finding positive. Using this criterion p-value, there were only 3 significant pairwise comparisons, one for each of the higher three dose groups and all at week 7 in the OC analyses.
Impression: We consider
this to be a negative study that cannot provide support for the antidepressant
efficacy of any of the four dose groups.
Study 212
(1)
Unadjusted
Results
The results in Table 3 were unadjusted for multiple comparisons, and even without such adjustment, these data did not suggest a consistent superiority for bupropion SR, at either dose, over placebo.
The results were strongest
for the 150 mg/day dose group, in particular for HAMD-21, MADRS, and CGI
Improvement. However, even for those
variables, there was little support in the OC analyses. There was very little support on either the
CGI Severity or the HAMD Item 1.
The results were very weak
for the 300 mg/day dose group, with scattered positive findings at early time
points and essentially no supportive findings later.
Back a Page
Next Page
Back to Wellbutrin SR® NDA Index Page
Back to Main
Index