Phase 2-3 Studies: Placebo Controlled Trials
|
Protocol |
Blind |
Design |
Centers |
Length |
Dosing |
Setting |
Diagnosis |
Levels |
Bupropion (po) |
N* |
|
203 |
Double |
Parallel Group |
6 |
8 weeks |
Fixed |
Outpatient |
Major Depression |
3 |
PBO am PBO pm |
117 |
|
150 mg am PBO pm |
120 |
|||||||||
|
150 mg am 150 mg pm |
116 |
|||||||||
|
205 |
Double |
Parallel Group |
11 |
8 weeks |
Fixed |
Outpatient |
Major Depression |
5 |
PBO am PBO pm |
118 |
|
50 mg am 50 mg pm |
115 |
|||||||||
|
100 mg am 100 mg pm |
115 |
|||||||||
|
150 mg am 150 mg pm |
113 |
|||||||||
|
200 mg am 200 mg pm |
114 |
*Number
of patients randomly assigned to treatment, after the exclusion of 9 patients
from protocol 203 and 27 patients from protocol 205 from whom no treatment
phase assessments were conducted.
Bupropion
Sustained-Release Clinical Review 46
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