Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

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

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
Generalized Anxiety Disorder
Drug: Eszopiclone (Lunesta)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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
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.


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00235508

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
Scottsdale, Arizona, United States
United States, California
Irvine, California, United States
La Mesa, California, United States
National City, California, United States
Oceanside, California, United States
Orange, California, United States
Pasadena, California, United States
Redlands, California, United States
Riverside, California, United States
San Diego, California, United States
United States, Connecticut
Farmington, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Coral Springs, Florida, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
St. Petersburg, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Augusta, Georgia, United States
Smyrna, Georgia, United States
United States, Illinois
Northfield, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kentucky
Owensboro, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
Rockville, Maryland, United States
United States, Massachusetts
Braintree, Massachusetts, United States
Brighton, Massachusetts, United States
Brockton, Massachusetts, United States
Cambridge, Massachusetts, United States
Watertown, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New Jersey
Kenilworth, New Jersey, United States
Piscataway, New Jersey, United States
United States, New York
Brooklyn, New York, United States
Lawrence, New York, United States
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, North Dakota
Bismarck, North Dakota, United States
United States, Ohio
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Middleburg Heights, Ohio, United States
United States, Oregon
Eugene, Oregon, United States
Portland, Oregon, United States
Salem, Oregon, United States
United States, Pennsylvania
Moon Township, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Scotland, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
Richardson, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
United States, Virginia
Falls Church, Virginia, United States
Richmond, Virginia, United States
United States, Wisconsin
Middleton, Wisconsin, United States
Sponsors and Collaborators
  More Information

Fava M, Schaefer K, Huang H, Wilson A, Iosifescu DV, Mischoulon D, Wessel TC. A post hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. Journal of Clinical Psychiatry 2010; doi::10.4088/JCP.09m05131gry

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunovion Identifier: NCT00235508     History of Changes
Other Study ID Numbers: 190-902
Study First Received: October 6, 2005
Last Updated: February 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Pathologic Processes
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014