|
Table 7.2.1.3.1 Reason from Premature
Study Discontinuation from Protocol 203 |
||||||
|
|
Bupropion
Sustained-Release Dosage Group |
|||||
|
150 mg/d (N=121) |
300 mg/d (N=120) |
Placebo (N=121) |
||||
|
# |
% of N |
# |
% of N |
# |
% of N |
|
|
Consent
Withdrawn |
22 |
18.2% |
22 |
18.3% |
21 |
17.4% |
|
Inadequate
Response/ Condition Deteriorated |
15 |
12.4% |
12 |
10.0% |
27 |
22.3% |
|
Adverse
Experience |
10 |
8.3% |
13 |
10.8% |
4 |
3.3% |
|
Lost
to Follow-up |
5 |
4.1% |
2 |
1.7% |
7 |
5.8% |
|
Protocol
Violation |
3 |
2.5% |
4 |
3.3% |
1 |
0.8% |
|
Total |
55 |
45.5% |
53 |
44.2% |
60 |
49.6% |
7.2.1.3.2
Demographic Characteristics
Appendix 7.2.1.3 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 or race, although fewer of the placebo-treatment patients (59%) were female than the drug-treated groups (75%). Sixty-three per cent, 57 per cent, and 63 per cent, respectively, of patients in the 150 mg, 300 mg, and placebo groups were experiencing a recurrent episode of depression. The three groups were roughly comparable as to characterization of the present episode as agitated vs. retarded vs. uncomplicated, or typical vs. atypical depression.
7.2.1.3.3
Baseline Illness Severity
Appendix 7.2.1.3 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). There were no statistically significant differences between groups.
7.2.1.3.4
Dosing Information
The
sponsor calculated mean daily dosages of medication intake as of the fourth 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 147 mg. The mean daily
dosage of bupropion sustained-release ingested by the 300 mg/d group was 290
mg.
7.2.1.3.5
Concomitant Medications
Concomitant
medication was administered to 75% of 150 mg/d patients, 71% of 300 mg/d
patients, and 64% of placebo patients.
The most common administered medications were non-narcotic analgesics,
miscellaneous cold preparations of antihistamines, female hormones or birth
control pills, and antibiotic or antiviral agents.
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