NCT00863798

Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 682 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Desvenlafaxine Succinate Sustained-Release 10mg	10 mg tablet, once daily dosing for 8 weeks
DRUG	Desvenlafaxine Succinate Sustained-Release 50 mg	50 mg tablet, once daily dosing for 8 weeks
DRUG	placebo	Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-03-18
• Last updated: 2011-05-06
• Results posted: 2011-05-06

Locations

24 sites across 1 country: United States