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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00445679 | Paroxetine-referenced Study Evaluating Three Doses of DVS SR in Outpatients With MDD | PHASE3 | COMPLETED | 807 | — | — | Jul 1, 2007 | Feb 1, 2009 | Nov 4, 2013 | 43 | China, India +2 |
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe, for a maximum total score of 50.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | DVS SR 50mg/day |
| B | EXPERIMENTAL | DVS SR 100mg/day |
| C | EXPERIMENTAL | DVS SR 200mg/day |
| D | ACTIVE_COMPARATOR | Paroxetine 20mg/day |
| Name | Type | Description |
|---|---|---|
| DVS SR | DRUG | Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper |
| Paroxetine | DRUG | 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper |
Primary Inclusion Criteria: 1. Outpatient men and women at least 18 years of age. 2. Have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), single or recurrent episode, without psychotic features. 3. Have a HAM D17 t...