At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 381 enrolled

Drug / intervention

Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) +1 moredrug

Likely dose

Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) 200mgfrom 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/NCT00369343

NCT00369343Phase 3Completed

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A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Aug 29, 2006·Updated May 7, 2012

In Brief

A Phase 3 clinical trial evaluating Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR) and Placebo for Depression and 2 related conditions. Completed, enrolled 381 participants across 37 sites.

Detailed Summary

Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied in the development program for the treatment of major depressive disorder (MDD), for vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri- and postmenopausal.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDepression, Depressive Disorder, Depressive Disorder, Major

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedAug 2006

Enrollment StartSep 2006

Primary CompletionNov 2007

Study CompletionJul 2008

TodayJul 2026

First PostedAug 29, 2006

Enrollment StartSep 1, 2006

Primary CompletionNov 1, 2007

Study CompletionJul 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 19.8 years ago

Interventions

Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)drug

DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks

Placebodrug

Placebo, daily (QD), tablet form, treatment period up to 8 weeks