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

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Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

This study has been completed.

Study NCT00235508. Last updated on October 9, 2008. Information provided by Sepracor, Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
Official Title ^†	The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
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.
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.
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	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 Measure ^†	Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Condition ^†	Insomnia Generalized Anxiety Disorder
Intervention ^†	Drug: Eszopiclone (Lunesta)
MEDLINE PMIDs
Links	Lunesta Patient's Instructions for Use

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	420
Start Date ^†	June 2005
Completion Date	April 2006
Eligibility Criteria ^†	Subjects, between the ages of 18 and 64 years inclusive Subjects with Generalized Anxiety Disorder (GAD) Subjects with insomnia related to GAD.
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00235508
Organization ID	190-902
Secondary IDs ^††
Study Sponsor ^†	Sepracor, Inc.
Collaborators ^††
Investigators ^†
Information Provided By	Sepracor, Inc.
Verification Date	October 2008
First Received Date ^†	October 6, 2005
Last Updated Date	October 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.