|
Week |
Daily Dose (mg) |
17-HAMD |
28-HAMD |
HAMD-#1 |
CGI-S |
CGI-I |
|||||
|
LOCF |
OC |
LOCF |
OC |
LOCF |
OC |
LOCF |
OC |
LOCF |
OC |
||
|
7 |
100 |
? |
?? |
? |
?? |
|
|
? |
?? |
? |
? |
|
200 |
|
|
|
?? |
|
|
|
|
? |
? |
|
|
300 |
|
? |
|
? |
|
|
|
? |
|
? |
|
|
400 |
|
? |
|
? |
|
|
|
|
|
? |
|
|
8 |
100 |
? |
|
? |
?? |
|
|
? |
|
? |
?? |
|
200 |
|
|
|
|
|
|
|
|
?? |
|
|
|
300 |
|
?? |
|
? |
|
|
|
|
|
|
|
|
400 |
|
? |
|
? |
|
?? |
|
|
|
|
|
7.2.2.3.6.1
17-Item HAMD
The
LOCF analyses showed p values of less than 0.05 favoring drug over placebo at
seven and eight weeks for 100 mg/d, at no time 200 mg/d or 300 mg/d, and at one
week for 400 mg/d. The OC analysis
showed p values of less than 0.05 favoring drug over placebo at no time for 100
mg/d or 300 mg/d, at three and seven weeks for 300 mg/d, and at one, seven, and
eight weeks for 400 mg/d. Had the
sponsor corrected their analysis for multiple-comparisons, no significant
differences would have been demonstrated at any time point. Fifty-seven of 112 (51%) 100 mg/d patients,
45 of 114 (39%0 200 mg/d patients, 43 of 111 (39%) 300 mg/d patients, 47 of 111
(42%) 400 mg/d patients, and 36 of 116 (33%) placebo patients were considered
treatment responders at time of discontinuation. Pearson chi-square analysis comparing the proportion of
responders across the treatment groups showed a trend towards (X2=8.22,
df=4, p=0.084), but no significant differences in response rates between the
individual groups.
7.2.2.3.6.2
28-Item HAMD
The
LOCF analyses showed p values of less than 0.05 favoring drug over placebo at
five through eight weeks for 100 mg/d, and at no times for 200, 300, or 400 mg/d.
The OC analysis showed p values of less than 0.05 favoring drug over
placebo at no times for 100 or 300 mg/d, at three and six through eight weeks
for 300 mg/d and at seven and eight weeks for 400 mg/d. Had the sponsor corrected their analysis for
multiple-comparisons, no significant differences would have been demonstrated
at any time point. Fifty-sex of 112
(50%) 100 mg/d patients, 47 of 114 (41%) 200 mg/d patients, 44 of 111 (404%)
300 mg/d patients, 47 of 11 (42%) 400 mg/d patients, and 39 of 116 (34%)
placebo patients were considered treatment responders at time of
discontinuation. Pearson chi-square
analysis comparing the proportion of responders across the treatment groups
showed no significant differences in response rates between groups (X2=6.49,
df=4, p=0.165).
7.2.2.3.6.3
HAMD-Item #1
The
LOCF analyses showed a p values of less than 0.05 favoring drug over placebo at
six weeks for 100 mg/d and at no other times or dosages. The OC analysis showed a p values [value]
of less than 0.05 favoring drug over placebo at no times or dosages. Had the sponsor corrected their analysis for
multiple-comparisons, no significant differences would have been demonstrated
at any time point.
Bupropion
Sustained-Release Clinical Review 22
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