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

Sponsor:	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

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

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 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 ]

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
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

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Locations

Austria

Wien, Austria, A-1090

Wien, Austria, A-1010

Salzburg, Austria
Croatia

Zagreb, Croatia, 10 000

Zagreb, Croatia, 10090

Split, Croatia, 21 000
France

Rennes, France, 35000

Toulouse, France, 31300

Toulouse, France

Caen, France, 14000

Strasbourg, France, 67100

Toulouse, France, 31000

Le Pecq, France, 78230

Verasailles, France, 78000

Savigny sur Orge, France

Arcachon, France

Elancourt, France, 78990
Hungary

Cegled, Hungary, 2700

Balassagyarmat, Hungary, 2660

Nyiregyhaza, Hungary, 4412

Budapest, Hungary, 1135

Budapest, Hungary, 1083

Budapest, Hungary, 1134
Poland

Torun, Poland, 87-100

Krakow, Poland, 31-530

Lodz, Poland, 90-130

Lublin, Poland, 20-109

Belchatow, Poland, 97-400

Tuszyn, Poland, 95-080

Bydgoszcz, Poland
Romania

Lasi, Romania, 700282

Oradea, Romania, 410154

Bucuresti, Romania, 041902
Russian Federation

Moscow, Russian Federation, 107076

Moscow, Russian Federation, 125367

St. Petersburg, Russian Federation, 190121

St. Petersburg, Russian Federation, 192019

Moscow, Russian Federation, 115522

Stavropol, Russian Federation, 355108

St. Petersburg, Russian Federation, 198020

Arkhangelsk, Russian Federation, 163001

St. Petersburg, Russian Federation, 191180

Belchatow, Russian Federation, 91-400

St. Petersburg, Russian Federation, 197341

St. Petersburg, Russian Federation, 194044
Serbia

Beograd, Serbia, 11 000

Kragujevac, Serbia, 34 000

Novi Sad, Serbia, 21 000

Beograd, Serbia, 11000

NIS, Serbia, 18000

NIS, Serbia
Ukraine

Vinnitsa, Ukraine, 21005

Crimea, Ukraine, 95006

Odessa, Ukraine, 65000

Kiev, Ukraine, 02660

Kiev, Ukraine, 03049

Lviv, Ukraine, 79021

Kiev, Ukraine, 04080

Dnepropetrovsk, Ukraine, 49005
Ukraine, Pobeda District

Donetsk, Pobeda District, Ukraine, 83037
United Kingdom

Haywards Heath, United Kingdom, RH16 4BE

Fowey, United Kingdom, PL23 1DT

Glasgow, United Kingdom, G20 OXA

Harrow, United Kingdom, HA13UJ

Plymouth, United Kingdom, PL6 7TH

Coventry, United Kingdom

Warks, United Kingdom, CV32 4RA
United Kingdom, Bath

Avon, Bath, United Kingdom, BA 1 2SR
United Kingdom, Scotland

Glasgow, Scotland, United Kingdom, G51 4TF

Sponsors and Collaborators

Sepracor, Inc.

Investigators

Study Chair:

Medical Director, CNS

Sepracor, Inc.

More Information

Additional Information:

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

No publications provided

Responsible Party:	Sepracor Inc. ( CNS Medical Director )
Study ID Numbers:	190-062
Study First Received:	February 12, 2007
Last Updated:	October 9, 2009
ClinicalTrials.gov Identifier:	NCT00435279 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Insomnia
Depression
Major Depressive Disorder

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Sleep Disorders
Depressive Disorder, Major
Sleep Disorders, Intrinsic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Venlafaxine

Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Depression
Nervous System Diseases
Dyssomnias
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009