536
patients. The intent-to-treat sample
consisted of 109 patients assigned to placebo, 107 patients assigned to 100
mg/d bupropion sustained-release, 106 patients assigned to 200 mg/d bupropion
sustained-release, 106 patients assigned to 300 mg/d bupropion
sustained-release, and 108 patients assigned to 400 mg/d bupropion
sustained-release. Sixty-nine per cent
of placebo patients, 71 per cent of 100 mg/d drug treated, 70 per cent of 200
mg/d drug-treated, 62 per cent of 300 mg/d drug-treated, and 65 per cent of 400
mg/d drug-treated patients completed the study. Overall, 361 patients (67% of the intent-to-treat sample)
completed the study. Appendix 7.2.2.3
shows the patient completion rates by week for each treatment group.
The
highest proportion of dropouts occurred in the 300 and 400 mg/d bupropion
sustained-release group and the lowest in the placebo and 100 mg/d drug
groups. An ill-characterized category
of “consent withdrawn” was the most common cause for early termination. Because some of the patients may have
experienced adverse events before withdrawing consent to participate, the
actual role of adverse experiences leading to premature study discontinuation
may be larger than stated by the sponsor.
Table 7.2.2.3.1 list reasons for premature discontinuation by treatment
group.
|
Table
7.2.2.3.1 Reasons
for Premature Study Discontinuation from Protocol 205 |
||||||||||
|
|
Bupropion
sustained-release Dosage Group: |
|||||||||
|
100 mg/d N=119 |
200 mg/d N=120 |
300 mg/d N=120 |
400 mg/d N=119 |
Placebo N=124 |
||||||
|
# |
% of N |
# |
% of N |
# |
% of N |
# |
% of N |
# |
% of N |
|
|
Consent
Withdrawn |
17 |
14.3% |
12 |
10.0% |
13 |
10.8% |
20 |
16.8% |
15 |
12.1% |
|
Inadequate Response/ Condition Deteriorated |
8 |
6.7% |
5 |
4.2% |
6 |
5.0% |
4 |
3.4% |
5 |
4.0% |
|
Adverse Experience |
2 |
1.7% |
9 |
7.5% |
13 |
10.8% |
12 |
10.1% |
7 |
5.6% |
|
Lost
to Follow-up |
6 |
5.0% |
9 |
7.5% |
14 |
11.7% |
6 |
5.0% |
9 |
7.3% |
|
Protocol
Violation |
5 |
4.2% |
7 |
5.8% |
5 |
4.2% |
1 |
0.8% |
3 |
2.4% |
|
Total |
38 |
31.9% |
42 |
35.0% |
51 |
42.5% |
43 |
36.1% |
39 |
31.5% |
7.2.2.3.2
Demographic Characteristics
Appendix
7.2.2.3 presents the demographic characteristics of the patients enrolled. The majority were female, consistent with
typical gender patterns for major depression.
There were no appreciable differences between treatment groups on the
basis of age, gender, or race.
Seventy-eight per cent, 66 per cent, 67 per cent, 71 per cent, and 69
percent, respectively, of patients in the 100 mg, 200 mg, 300 mg, 400 mg, and
placebo groups were experiencing a recurrent episode of depression. The five groups were roughly comparable as
to characterization of the present episode as agitated vs. retarded vs.
uncomplicated, or typical vs. atypical depression.
7.2.2.3.3
Baseline Illness Severity
Appendix
7.2.2.3 presents the baseline and follow-up measures of illness severity. Pairwise contrasts of baseline symptom
scores on the efficacy measures across treatment groups based on means and
standard deviations
Bupropion
Sustained-Release Clinical Review 19
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