Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00235508
First received: October 6, 2005
Last updated: February 21, 2012
Last verified: February 2012

October 6, 2005
February 21, 2012
June 2005
April 2006   (final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00235508 on ClinicalTrials.gov Archive Site
Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Insomnia
  • Generalized Anxiety Disorder
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta
  • Active Comparator: 1
    Escitalopram oxalate 10 mg at bedtime
    Intervention: Drug: Eszopiclone (Lunesta)
  • Active Comparator: 2
    Eszopiclone 3 mg at bedtime
    Intervention: Drug: Eszopiclone (Lunesta)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
April 2006
April 2006   (final data collection date for primary outcome measure)
  • Subjects, between the ages of 18 and 64 years inclusive
  • Subjects with Generalized Anxiety Disorder (GAD)
  • Subjects with insomnia related to GAD.
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00235508
190-902
No
Sunovion
Sunovion
Not Provided
Not Provided
Sunovion
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP