CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 709 enrolled
Drug / intervention
Desvenlafaxine Succinate Sustained-Release (DVS SR) +2 moredrug
Likely dose
Desvenlafaxine Succinate Sustained-Release (DVS SR) 25 mgfrom 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/NCT00798707
NCT00798707Phase 3Completed

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

Pfizer·interventional·Posted Nov 26, 2008·Updated Jun 10, 2011

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2008
Enrollment StartDec 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.6 years ago

Interventions

Desvenlafaxine Succinate Sustained-Release (DVS SR)drug

25 mg tablet, once daily dosing for 8 weeks

Desvenlafaxine Succinate Sustained-Release (DVS SR)drug

50 mg tablet, once daily dosing for 8 weeks

placebodrug

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.