Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

NCT ID: NCT00235508

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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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. 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.

Conditions

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Insomnia Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Escitalopram oxalate 10 mg at bedtime

Group Type ACTIVE_COMPARATOR

Eszopiclone (Lunesta)

Intervention Type DRUG

Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

2

Eszopiclone 3 mg at bedtime

Group Type ACTIVE_COMPARATOR

Eszopiclone (Lunesta)

Intervention Type DRUG

Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

Interventions

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Eszopiclone (Lunesta)

Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

Intervention Type DRUG

Other Intervention Names

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Lunesta

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wichita Falls, Texas, United States

Site Status

Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Middleton, Wisconsin, United States

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Birmingham, Alabama, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Irvine, California, United States

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La Mesa, California, United States

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National City, California, United States

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Oceanside, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Redlands, California, United States

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Riverside, California, United States

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San Diego, California, United States

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Farmington, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Coral Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Smyrna, Georgia, United States

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Northfield, Illinois, United States

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Indianapolis, Indiana, United States

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Owensboro, Kentucky, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Braintree, Massachusetts, United States

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Brighton, Massachusetts, United States

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Brockton, Massachusetts, United States

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Cambridge, Massachusetts, United States

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Watertown, Massachusetts, United States

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St Louis, Missouri, United States

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Kenilworth, New Jersey, United States

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Piscataway, New Jersey, United States

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Brooklyn, New York, United States

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Lawrence, New York, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Middleburg Heights, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Moon Township, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Richardson, Texas, United States

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San Antonio, Texas, United States

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Countries

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United States

References

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Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, Wessel TC. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. J Clin Psychiatry. 2011 Apr;72(4):473-9. doi: 10.4088/JCP.09m05131gry. Epub 2010 Nov 2.

Reference Type RESULT
PMID: 21208574 (View on PubMed)

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. doi: 10.1001/archpsyc.65.5.551.

Reference Type DERIVED
PMID: 18458207 (View on PubMed)

Other Identifiers

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190-902

Identifier Type: -

Identifier Source: org_study_id

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