Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder - Full Text View

Sponsor:	Sepracor, Inc.
Information provided by:	Sepracor, Inc.
ClinicalTrials.gov Identifier:	NCT00235508

Purpose

To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

Condition	Intervention	Phase
Insomnia Generalized Anxiety Disorder	Drug: Eszopiclone (Lunesta)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Sepracor, Inc.:

Primary Outcome Measures:

The change from baseline in subjective sleep latency averaged over the double-blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	420
Study Start Date:	June 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Escitalopram oxalate 10 mg at bedtime	Drug: Eszopiclone (Lunesta) Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
2: Active Comparator Eszopiclone 3 mg at bedtime	Drug: Eszopiclone (Lunesta) Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

Detailed Description:

An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks.

Eligibility

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

Criteria

Subjects, between the ages of 18 and 64 years inclusive
Subjects with Generalized Anxiety Disorder (GAD)
Subjects with insomnia related to GAD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235508

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Locations

United States, Alabama

Birmingham, Alabama, United States
United States, Arizona

Mesa, Arizona, United States

Scottsdale, Arizona, United States
United States, California

San Diego, California, United States

Oceanside, California, United States

National City, California, United States

Orange, California, United States

Redlands, California, United States

Irvine, California, United States

La Mesa, California, United States

Pasadena, California, United States

Riverside, California, United States
United States, Connecticut

Farmington, Connecticut, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Florida

Fort Lauderdale, Florida, United States

St. Petersburg, Florida, United States

Gainesville, Florida, United States

Coral Springs, Florida, United States

Jacksonville, Florida, United States

Pembroke Pines, Florida, United States

Orlando, Florida, United States
United States, Georgia

Atlanta, Georgia, United States

Smyrna, Georgia, United States

Augusta, Georgia, United States
United States, Illinois

Northfield, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Kentucky

Owensboro, Kentucky, United States
United States, Maryland

Rockville, Maryland, United States

Baltimore, Maryland, United States
United States, Massachusetts

Cambridge, Massachusetts, United States

Brockton, Massachusetts, United States

Brighton, Massachusetts, United States

Braintree, Massachusetts, United States

Watertown, Massachusetts, United States
United States, Missouri

St. Louis, Missouri, United States
United States, New Jersey

Kenilworth, New Jersey, United States

Piscataway, New Jersey, United States
United States, New York

New York, New York, United States

Lawrence, New York, United States

Brooklyn, New York, United States
United States, North Carolina

Durham, North Carolina, United States

Winston-Salem, North Carolina, United States

Raleigh, North Carolina, United States
United States, North Dakota

Bismarck, North Dakota, United States
United States, Ohio

Middleburg Heights, Ohio, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Beachwood, Ohio, United States
United States, Oregon

Eugene, Oregon, United States

Salem, Oregon, United States

Portland, Oregon, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Moon Township, Pennsylvania, United States

Scotland, Pennsylvania, United States
United States, South Carolina

Columbia, South Carolina, United States
United States, Tennessee

Memphis, Tennessee, United States
United States, Texas

Austin, Texas, United States

San Antonio, Texas, United States

Houston, Texas, United States

Richardson, Texas, United States

Wichita Falls, Texas, United States
United States, Virginia

Richmond, Virginia, United States

Falls Church, Virginia, United States
United States, Wisconsin

Middleton, Wisconsin, United States

Sponsors and Collaborators

Sepracor, Inc.

More Information

Additional Information:

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

No publications provided by Sepracor, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, Rubens R, Roach J, Huang H, Krishnan R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008 May;65(5):551-62.

Responsible Party:	Sepracor Inc. ( Executive Medical Director, Clinical Research )
Study ID Numbers:	190-902
Study First Received:	October 6, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00235508 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Insomnia
Anxiety
Generalized Anxiety Disorder

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Nervous System Diseases
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 22, 2009