CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 682 enrolled
Drug / intervention
Desvenlafaxine Succinate Sustained-Release 10mg +2 moredrug
Likely dose
Desvenlafaxine Succinate Sustained-Release 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00863798
NCT00863798Phase 3Completed

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

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Mar 18, 2009·Updated May 6, 2011

In Brief

A Phase 3 clinical trial evaluating Desvenlafaxine Succinate Sustained-Release 10mg, Desvenlafaxine Succinate Sustained-Release 50 mg, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 682 participants across 24 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2009
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.3 years ago

Interventions

Desvenlafaxine Succinate Sustained-Release 10mgdrug

10 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine Succinate Sustained-Release 50 mgdrug

50 mg tablet, once daily dosing for 8 weeks

placebodrug

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.