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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435279

Enrollment

678

Registered

2007-02-14

Start date

2007-06-30

Completion date

2009-07-31

Last updated

2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Major Depressive Disorder

Keywords

Insomnia, Depression, Major Depressive Disorder

Brief 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.

Interventions

DRUGEszopiclone

Eszopiclone 3 mg

DRUGPlacebo

Placebo

DRUGVenlafaxine

Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
The key secondary endpoint is the change from baseline in the mean subjective Total Sleep Time (TST) during Week 1.	Week 1

Countries

Austria, Croatia, France, Hungary, Poland, Romania, Russia, Serbia, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026