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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00429260 | A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression | PHASE3 | COMPLETED | 125 | — | — | Jan 1, 2007 | Jun 1, 2007 | Feb 17, 2012 | 1 | United States |
| NCT00415142 | An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder | PHASE3 | COMPLETED | 393 | — | — | Dec 1, 2006 | Feb 1, 2008 | May 24, 2016 | 8 | United States, Croatia +6 |
| NCT00336713 | A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA) | PHASE3 | COMPLETED | 430 | — | — | May 1, 2006 | Apr 1, 2008 | May 13, 2016 | 1 | United States |
| NCT00250653 | A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression | PHASE3 | COMPLETED | 365 | — | — | May 1, 2005 | Apr 1, 2007 | Feb 17, 2012 | 1 | United States |
| NCT00250601 | An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression | PHASE3 | COMPLETED | 460 | — | — | Apr 1, 2005 | Jul 1, 2007 | Feb 17, 2012 | 1 | United States |
| NCT00250614 | An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression | PHASE3 | COMPLETED | 452 | — | — | Apr 1, 2005 | Oct 1, 2006 | Jun 9, 2010 | 1 | United States |
| NCT00250627 | An Eight-Week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression | PHASE3 | COMPLETED | 465 | — | — | Dec 1, 2004 | Dec 1, 2006 | Dec 23, 2008 | 8 | Canada, Chile +6 |
| NCT00256113 | An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression | PHASE3 | COMPLETED | 467 | — | — | Dec 1, 2004 | Dec 1, 2006 | Apr 20, 2018 | 8 | Canada, Chile +6 |
| Arm | Type | Description |
|---|---|---|
| Saredutant 100 mg | EXPERIMENTAL | Saredudant100 mg once daily for a maximum of 32 weeks |
| Escitalopram 10 mg | ACTIVE_COMPARATOR | Escitalopram 10 mg once daily for a maximum of 32 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase |
| Name | Type | Description |
|---|---|---|
| Saredutant | DRUG | - |
| saredutant (SR48968) | DRUG | oral administration (capsules) |
| placebo | DRUG | oral administration (capsules) |
| escitalopram | DRUG | oral administration (capsules) |
| Saredutant (SR48968C) | DRUG | oral administration (capsules) |
| Saredutant succinate (SR48968C) | DRUG | - |
Inclusion Criteria: * Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria Exclusion Criteria: * Total score of \<22 on the Montgomery-Asberg Depression Rating Scale (MADRS). * Duration of the curre...