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Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235508
First Posted: October 10, 2005
Last Update Posted: February 22, 2012
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.
Information provided by (Responsible Party):
Sunovion
  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 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sunovion:

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

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

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
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

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.
  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00235508


  Show 64 Study Locations
Sponsors and Collaborators
Sunovion
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00235508     History of Changes
Other Study ID Numbers: 190-902
First Submitted: October 6, 2005
First Posted: October 10, 2005
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Sunovion:
Insomnia
Anxiety
Generalized Anxiety Disorder

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