|
Table
AD7.2.3.3.1 Reasons
for Premature Study Discontinuation From Protocol 212 |
||||||
|
|
Bupropion
Sustained-Release Dosage Group |
|||||
|
150 mg/d (N=152) |
300 mg/d (N=150) |
Placebo N=154) |
||||
|
# |
% of N |
# |
% of N |
# |
% of N |
|
|
Inadequate Response/ Condition Deteriorated |
5 |
3.3% |
17 |
11.3% |
13 |
8.4% |
|
Adverse Experience |
5 |
3.3% |
7 |
4.7% |
3 |
1.9% |
|
Lost to Follow-up/Other |
1 |
0.7% |
2 |
1.3% |
6 |
3.9% |
|
Consent Withdrawn |
15 |
9.9% |
14 |
9.3% |
17 |
11.0% |
|
Protocol Violation |
7 |
4.6% |
7 |
4.7% |
9 |
5.8% |
|
Total |
33 |
21.7% |
47 |
31.3% |
48 |
31.2% |
AD7.2.3.3.2 Demographic Characteristics
Table AD5.1.2.2 above presents the demographic 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 or race. Seventy-one per cent, 7 per cent, and 69 per cent, respectively,
of patients in the 150 mg, 300 mg, and placebo groups were experienced a
recurrent episode of depression. The
three groups were roughly comparable as to characterization of the present
episode as agitated vs. retarded vs. uncomplicated depression.
AD7.2.3.3.3 Baseline Illness Severity
Appendix AD7.2.3.3 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 supplied by the sponsor were
performed using t-tests (cf: Stanton A. Glantz, Primer of Biostatistics,
1992, p. 81). After corrections for
multiple comparisons testing, there were no statistically significant
differences between groups.
AD7.2.3.3.4 Dosing Information
The sponsor calculated mean daily dosages of medication
intake from the eighth day of the study (by which time patients had been
titrated up to the full dosage level) through day of discontinuation. The mean daily dose of bupropion
sustained-release ingested by the 150 mg/d group was 144 mg. The mean daily dose of bupropion
sustained-release ingested by the 300 mg/d group was 276 mg.
AD7.2.3.3.5 Concomitant Medications
Concomitant medication was administered to 70% of
150 mg/d patients, 75% of 300 mg/d patients, and 67% of placebo patients. The most commonly administered medications
were non-narcotic analgesics, miscellaneous cold preparations or
antihistamines, female hormones or birth control pills, and antibiotic or
antiviral agents.
Bupropion SR Clinical Review Addendum for Protocol
212 6
Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index