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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00822744 | An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients | PHASE2 | COMPLETED | 527 | — | — | Dec 1, 2008 | Feb 1, 2010 | Mar 15, 2013 | 7 | Chile, Mexico +5 |
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...