Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235508
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : February 22, 2012
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Brief Summary:
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 or disease Intervention/treatment Phase
Insomnia Generalized Anxiety Disorder Drug: Eszopiclone (Lunesta) Phase 4

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. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
Study Start Date : June 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Eszopiclone
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Escitalopram oxalate 10 mg at bedtime
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta
Active Comparator: 2
Eszopiclone 3 mg at bedtime
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta

Primary Outcome Measures :
  1. The change from baseline in subjective sleep latency averaged over the double-blind treatment period. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Subjects, between the ages of 18 and 64 years inclusive
  • Subjects with Generalized Anxiety Disorder (GAD)
  • Subjects with insomnia related to GAD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235508

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Sponsors and Collaborators

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunovion Identifier: NCT00235508     History of Changes
Other Study ID Numbers: 190-902
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Sunovion:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs