NCT00435279

A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia

A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered With Venlafaxine in Subjects With Major Depressive Disorder (MDD) and Co-existing Insomnia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

Detailed description

This is a double-blind, randomized, placebo-controlled, parallel-group study. The study consists of two groups of subjects with Major Depressive Disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of Visit 2. In addition, all subjects will receive open-label treatment with venlafaxine. Safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Major Depressive Disorder
• Insomnia

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3 mg
DRUG	Placebo	Placebo
DRUG	Venlafaxine	Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-02-14
• Last updated: 2012-02-22

Locations

69 sites across 10 countries: Austria, Croatia, France, Hungary, Poland, Romania, Russia, Serbia, Ukraine, United Kingdom