Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

February 21, 2012 updated by: Sunovion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

420

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
      • Scottsdale, Arizona, 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
    • Connecticut
      • Farmington, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, 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
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Smyrna, Georgia, United States
    • Illinois
      • Northfield, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Owensboro, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Braintree, Massachusetts, United States
      • Brighton, Massachusetts, United States
      • Brockton, Massachusetts, United States
      • Cambridge, Massachusetts, United States
      • Watertown, Massachusetts, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Kenilworth, New Jersey, United States
      • Piscataway, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Lawrence, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
    • Ohio
      • Beachwood, Ohio, United States
      • Cincinnati, Ohio, United States
      • Dayton, Ohio, United States
      • Middleburg Heights, Ohio, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
      • Salem, Oregon, United States
    • Pennsylvania
      • Moon Township, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Scotland, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, 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
    • Virginia
      • Falls Church, Virginia, United States
      • Richmond, Virginia, United States
    • Wisconsin
      • Middleton, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Subjects, between the ages of 18 and 64 years inclusive
  • Subjects with Generalized Anxiety Disorder (GAD)
  • Subjects with insomnia related to GAD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Lunesta
Active Comparator: 2
Eszopiclone 3 mg at bedtime
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Names:
  • Lunesta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in subjective total sleep time averaged over the double blind treatment period.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190-902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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