AD5.1.3 Extent of Exposure (dose/duration)
Table AD5.1.3 shows the numbers of patients in
protocol 212 according to mean daily bupropion sustained-release dose and
duration of administration. The
plurality of patients studied (48.4%) were treated with 150 mg/day. This trial represents 49 patients-years of
exposure to bupropion sustained-release.
|
Table
AD5.1.3 Number and Percentage of
All Patients Receiving Bupropion Sustained-Release According to Mean Daily Dose*
and Duration in Study 212** |
|||||||
|
Durations (days) |
100 mg |
150 mg |
200mg |
300 mg |
400 mg |
Total |
Percentage |
|
1-6 |
0 |
0 |
0 |
0 |
0 |
0 |
0% |
|
7-13 |
1 |
4 |
1 |
6 |
0 |
12 |
4.1% |
|
14-20 |
3 |
1 |
0 |
6 |
0 |
10 |
3.4% |
|
21-27 |
1 |
5 |
3 |
6 |
0 |
15 |
5.2% |
|
28-34 |
1 |
5 |
0 |
5 |
0 |
11 |
3.8% |
|
35-41 |
1 |
4 |
0 |
9 |
0 |
14 |
4.8% |
|
42-48 |
0 |
2 |
0 |
1 |
0 |
3 |
1.0% |
|
49-55 |
0 |
20 |
1 |
20 |
0 |
41 |
14.1% |
|
56 |
3 |
100 |
10 |
72 |
0 |
185 |
63.6% |
|
Total |
10 |
141 |
15 |
125 |
0 |
291 |
(blacked out) |
|
Percentage |
3.4% |
48.2% |
5.2% |
43.0% |
0% |
(blacked out) |
100 |
*mean daily dose categories are based on the
following dose ranges: 100 mg = ≤ 125 mg; 150 mg = 126-175 mg; 200 mg =
176-250 mg; 300 mg = 251-350 mg.
** A total of 3 patients from Study 212 did not receive
study medication beyond the initial titration period and were excluded from the
above table.
AD7.0 Efficacy
Findings
AD7.1 Overview
of Study 212
Study 212 was intended to explore antidepressant
efficacy of two intended dosing levels of bupropion sustained-release. It was a U.S. placebo-controlled fixed dose
study.
AD7.2.3 Study
212
AD72.3.1 Investigators
and Location
Six U.S.A. sites participated in this trial. The principal investigators were L.A.
Cunningham at the Vine Street Clinic, Springfield, IL, D. Dunner at the
University of Washington, Seattle, WA, L.F. Fabre at the Fabre Research
Clinics, Houston, TX, C. Merideth of San Diego, CA, E.C. Settle, JR. of
Charleston WV, and R Weisler of Raleigh, NC.
Bupropion SR Clinical Review: Addendum for Protocol
212 3
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