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SSR411298 · 1 trial · 1 indication
The HAM-D consists of 17 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 52, respectively.
| Arm | Type | Description |
|---|---|---|
| SSR411298 10 mg | EXPERIMENTAL | SSR411298 10 mg, one capsule once daily for 8 weeks |
| SSR411298 50 mg | EXPERIMENTAL | SSR411298 50 mg, one capsule once daily for 8 weeks |
| SSR411298 200 mg | EXPERIMENTAL | SSR411298 200 mg, one capsule once daily for 8 weeks |
| Escitalopram 10 mg | ACTIVE_COMPARATOR | Escitalopram 10 mg, one capsule once daily for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo (for SSR411298), one capsule once daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| SSR411298 | DRUG | Form: capsule Route: oral administration with food |
| Escitalopram | DRUG | Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food |
| Placebo (for SSR411298) | DRUG | Form: capsule Route: oral administration with food |
Inclusion Criteria: * Elderly patient with recurrent Major Depressive Disorder Exclusion Criteria: * Duration of current depressive episode greater than 2 years; * Mild depression as measured by standard clinical research scales; * Cognitive disturbance; * Significant suicide risk; * Other psychi...
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SSR411298 is an investigational small molecule being studied for the treatment of Major Depressive Disorder (MDD). It was evaluated in a Phase 2 clinical trial specifically in elderly patients aged 60 years and older. The drug is not approved and remains in clinical development.
SSR411298 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi conducted a Phase 2 clinical trial of SSR411298 for Major Depressive Disorder in elderly patients.
SSR411298 is in Phase 2 clinical development. It has completed one Phase 2 trial for Major Depressive Disorder in elderly patients. The drug is investigational and has not been approved by regulatory authorities.
SSR411298 has one completed clinical trial, registered as NCT00822744. This was an eight-week, randomized, double-blind, placebo-controlled Phase 2 study evaluating SSR411298 as treatment for Major Depressive Disorder in elderly patients. The trial enrolled 527 participants across seven countries.
No, SSR411298 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for Major Depressive Disorder in elderly patients. The drug remains in clinical development and has not received regulatory approval.