Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as paroxetine IR 10mg tablet
Paroxetine IR · 1 trial · 1 indication
The HAM-D measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms. Mean change from baseline was calculated as the value at Week 8 minus the Baseline value.
| Arm | Type | Description |
|---|---|---|
| paroxetine CR group | EXPERIMENTAL | controlled-release (CR) of paroxetine 12.5 to 50mg/day |
| paroxetine IR group | OTHER | Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm |
| placebo group | PLACEBO_COMPARATOR | matched placebo to both paroxetine CR and paroxetine IR |
| Name | Type | Description |
|---|---|---|
| paroxetine IR 10mg tablet | DRUG | 1 or 2 tablets once a day |
| paroxetine IR 20mg tablet | DRUG | 1 tablet once a day |
| matched placebo to paroxetine IR 10mg or 20mg | DRUG | 1 or 2 tablets once a day |
| Paroxetine CR 12.5mg tablet | DRUG | 1 or 2 tablets once a day |
| Paroxetine CR 25mg tablet | DRUG | 1 or 2 tablets once a day |
| matched placebo to paroxetine CR 12.5mg or 25mg | DRUG | 1 or 2 tablets once a day |
Inclusion Criteria: \<at the start of placebo run-in phase\> Only the patients who meet all of the following conditions at Week -1 (at the start of placebo run-in phase) will be enrolled in this study. The hospitalization status will be no object. and Gender: No object. * Target disease: Patients ...
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