Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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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Paroxetine IR is an immediate-release small molecule developed by GSK plc (ticker GSK) for depressive disorder. It is a Phase 3 investigational therapy in the psychiatry therapeutic area. The clinical program includes one completed Phase 3 trial that enrolled 416 participants.
Paroxetine IR is being developed for depressive disorder. It is an investigational small molecule in Phase 3 development, and the completed trial in the program evaluated treatment in major depressive disorder. It has not been established as an approved treatment based on the available development information.
Paroxetine IR targets SLC6A4, the serotonin transporter. It is classified as an inhibitor of this target. By inhibiting SLC6A4, the drug acts on serotonin reuptake, which is the mechanism under investigation for depressive disorder.
Paroxetine IR is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this immediate-release small molecule in depressive disorder.
Paroxetine IR is in Phase 3 development. The program includes one completed Phase 3 trial, and no active trials are currently listed. It is an investigational agent and has not been established as approved for any indication based on the development information available.
Paroxetine IR has been studied in NCT00866294, a Phase 3, double-blind, placebo-controlled trial in major depressive disorder. The trial enrolled 416 participants, was randomized, and has been completed. It was conducted in Japan and South Korea with participants aged 20 years and older.