Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00296517 | Study In Patients With Depression Not Responding to Selective Serotonin Re-uptake Inhibitors | PHASE3 | COMPLETED | 325 | — | — | Jan 19, 2006 | Mar 28, 2008 | Dec 4, 2019 | 62 | Japan |
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. |
| Bupropion SR | EXPERIMENTAL | Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. |
| Name | Type | Description |
|---|---|---|
| 323U66 (Bupropion Hydrochloride Sustained Release) | DRUG | Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg. |
| Placebo | DRUG | Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period. |
Inclusion criteria: * \[At the start of the pretreatment phase\] * Target disease: Patients diagnosed as having the following primary disease on the basis of DSM-IV-TR criteria. * Major Depressive Disorder, Single Episode (296.2x) (excluding with psychotic features) * Major Depressive Disorder, Rec...