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

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

MedlinePlus related topics:

Anxiety

Drug Information available for:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate 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:	The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

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

Show 64 Study Locations

Sponsors and Collaborators

Sepracor, Inc.

More Information

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

Publications indexed to this study:

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
First Received:	October 6, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00235508
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sepracor, Inc.:

Insomnia

Anxiety

Generalized Anxiety Disorder

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders

Anxiety Disorders

Mental Disorders

Dyssomnias

Sleep Disorders

Dexetimide

Citalopram

Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes

Disease

Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

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