NCT00368030

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

Depression Response to Eszopiclone in Adults With Major Depressive Disorder (DREAMDD): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 8-Week, Safety & Efficacy Study of Eszopiclone 3 mg Compared to Placebo in Subjects With Insomnia Related to MDD Acronym: DREAMDD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia related to major depressive disorder.

Detailed description

This study is a double-blind, randomized, placebo-controlled, parallel group study. The study consists of two groups of subjects with major depression treated for ten weeks with a common antidepressant regimen, 20-40 mg of fluoxetine hydrochloride per day; and randomized to receive (in addition) either eszopiclone 3 mg or placebo for eight weeks. 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

• Insomnia
• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Eszopiclone	Eszopiclone 3 mg QD
OTHER	Placebo	Placebo tablet

Timeline

• Start date: 2004-01-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2006-08-24
• Last updated: 2012-02-22

Locations

65 sites across 1 country: United States