A Study of Eszopiclone Co-Administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia - Full Text View

Sponsored by:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00435279

Purpose

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

Condition	Intervention	Phase
Major Depressive Disorder Insomnia	Drug: Eszopiclone Drug: Placebo Drug: Venlafaxine	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Eszopiclone

U.S. FDA Resources

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

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	640
Study Start Date:	June 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Eszopiclone: Experimental	Drug: Eszopiclone Eszopiclone 3 mg Drug: Venlafaxine Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28
Placebo: Experimental	Drug: Placebo Placebo Drug: Venlafaxine Venlafaxine 75 mcg Weeks 1, 2, 29, and 30 Venlafaxine 150 mcg Weeks 3 through 28

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435279

Show 68 Study Locations

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Chair:

Medical Director, CNS

Sepracor, Inc.

More Information

Lunesta Patient Instructions for Use This link exits the ClinicalTrials.gov site

Responsible Party:	Sepracor Inc. ( Judith Dunn, Ph.D. )
Study ID Numbers:	190-062
Study First Received:	February 12, 2007
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00435279
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Insomnia
Depression
Major Depressive Disorder

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Depression
Mental Disorders
Venlafaxine
Mood Disorders
Dyssomnias

Sleep Disorders
Depressive Disorder, Major
Depressive Disorder
Serotonin
Sleep Disorders, Intrinsic
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 13, 2009