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

Official Title: “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”

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

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Eszopiclone
• Experimental: Placebo

Primary Measures

• The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.
  • Time Frame: Week 8
    Safety Issue?: Yes

Secondary Measures

• The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.
  • Time Frame: Week 1
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent.
• Subjects must have a primary diagnosis of Major Depressive Disorder (MDD) by DSM-IV criteria (296.XX) as determined by the Mini International Neuropsychiatric Interview (M.I.N.I.).
• MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
• Subjects must have a 17-item Hamilton Depression Scale (HAM-D-17) total score of > 22 at the screening visit.

Exclusion Criteria:

• Subjects who have a HAM-D-17 total score < 18 at Visit 2 will be discontinued from the study.
• All subjects who do not meet DSM-IV criteria (307.42) for Insomnia related to a Major
• Depressive Disorder.
• Subjects with less than a total sleep time < 6.5 hours at least three times per week over the past month.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sunovion Industry

Overall Clinical Trial Officials and Contacts

Medical Director, CNS Study Chair Sunovion  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00435279

Study ID Number: 190-062

ClinicalTrials.gov Identifier: NCT00435279

Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices

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