At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (25 and 50 mg/Day) of DVS SR Tablets in Adult Outpatients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) and placebo for Major Depressive Disorder. Completed, enrolled 709 participants across 78 sites in 2 countries.
Detailed Summary
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.
Study Details
Timeline
Interventions
25 mg tablet, once daily dosing for 8 weeks
50 mg tablet, once daily dosing for 8 weeks
Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.