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A Multicenter, Randomized, Double-blind, Paroxetine-referenced, Parallel-group Study to Evaluate the Safety, Efficacy, and Tolerability of 3 Fixed Doses (50mg, 100mg, AND 200mg) of Desvenlafaxine Succinate Sustained-release Tablets in Adult Outpatients With Major Depressive Disorder
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.
Details
| Lead sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 807 |
| Start date | 2007-07 |
| Completion | 2009-02 |
Conditions
- Depressive Disorder, Major
Interventions
- DVS SR
- Paroxetine
Primary outcomes
- Percentage of Responders With a 50% or Greater Decrease From Baseline on the Hamilton Rating Scale for Depression, 17-item (HAM-D17) — 8 weeks
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.
Countries
China, India, South Korea, Taiwan