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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01034995 | A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder | PHASE2 | COMPLETED | 580 | — | — | Feb 1, 2010 | Mar 1, 2011 | Apr 14, 2011 | 73 | Belgium, Canada +10 |
| Arm | Type | Description |
|---|---|---|
| SSR125543 20 mg | EXPERIMENTAL | 1 capsule of SSR125543 20 mg + 1 capsule of placebo |
| SSR125543 50 mg | EXPERIMENTAL | 1 capsule of SSR125543 50 mg + 1 capsule of placebo |
| SSR125543 100 mg | EXPERIMENTAL | 2 capsules of SSR125543 50 mg |
| escitalopram 10 mg | ACTIVE_COMPARATOR | 1 capsule of escitalopram 10 mg + 1 capsule of placebo |
| placebo | PLACEBO_COMPARATOR | 2 capsules of placebo |
| Name | Type | Description |
|---|---|---|
| SSR125543 | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| escitalopram | DRUG | Pharmaceutical form: encapsulated tablets Route of administration: oral |
| placebo | DRUG | Pharmaceutical form: capsule Route of administration: oral |
Inclusion criteria: * Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI). ...