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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

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.

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 Sponsor: Sepracor, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director, CNS Study Chair Sepracor, Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

Study ID Number: 190-062

ClinicalTrials.gov Identifier: NCT00435279

Health Authority: United States: Food and Drug Administration

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