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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Major Depressive Disorder, Insomnia

Intervention / Treatment
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* Drug: Eszopiclone
* Drug: Placebo
* Drug: Venlafaxine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eszopiclone<br> | Drug: Eszopiclone<br>* Eszopiclone 3 mg<br>* Other names: Lunesta;Drug: Venlafaxine<br>* Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28<br>* Other names: Effexor;|
| Experimental: Placebo<br> | Drug: Placebo<br>* Placebo<br>Drug: Venlafaxine<br>* Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28<br>* Other names: Effexor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1. |  | Week 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Depression, Major Depressive Disorder