NCT00369343

Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR)	DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks
DRUG	Placebo	Placebo, daily (QD), tablet form, treatment period up to 8 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-11-01
• Completion: 2008-07-01
• First posted: 2006-08-29
• Last updated: 2012-05-07
• Results posted: 2012-05-07

Locations

37 sites across 1 country: United States