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Completed

NCT Number: NCT00235508

Safety and Efficacy of Eszopiclone in Patients With 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.

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Key information

Conditions

Insomnia Anxiety Disorders Dyssomnias Generalized Anxiety Disorder Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eszopiclone (Lunesta)

Drug

Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

Other names: Lunesta

Primary outcomes

  1. The change from baseline in subjective sleep latency averaged over the double-blind treatment period.

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline in subjective total sleep time averaged over the double blind treatment period.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 10, 2005
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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