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

Sponsor:	Sunovion
Information provided by:	Sunovion
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Eszopiclone

U.S. FDA Resources

Further study details as provided by Sunovion:

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 ]

Enrollment:	678
Study Start Date:	June 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

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

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.

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 69 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Chair:

Medical Director, CNS

Sunovion

More Information

Additional Information:

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

No publications provided

Responsible Party:	CNS Medical Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00435279 History of Changes
Other Study ID Numbers:	190-062
Study First Received:	February 12, 2007
Last Updated:	November 1, 2010
Health Authority:	Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Serbia: Ethics Committee

Keywords provided by Sunovion:

Insomnia
Depression
Major Depressive Disorder

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Venlafaxine
Eszopiclone
Serotonin Uptake Inhibitors

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Central Nervous System Depressants

ClinicalTrials.gov processed this record on February 12, 2012