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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Duloxetine-Referenced, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50mg, 100mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder
The primary purpose of this study is to evaluate the efficacy and safety of two doses of DVS SR (50 and 100 mg/day) in the treatment of adults with Major Depressive Disorder.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 638 |
| Start date | 2006-09 |
| Completion | 2007-09 |
Conditions
- Depressive Disorder, Major
Interventions
- Desvenlafaxine Succinate Sustained-Release (DVS SR)
- Desvenlafaxine Succinate Sustained-Release (DVS SR)
- Placebo
- Duloxetine 60 mg/day
Primary outcomes
- Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation — Baseline and Week 8 or FOT
HAM-D17: 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
United States