Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235508
• Other study ID #: 190-902
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2005
• Last updated: February 21, 2012
• Start date: June 2005
• Est. completion date: April 2006

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

• Subjects, between the ages of 18 and 64 years inclusive

• Subjects with Generalized Anxiety Disorder (GAD)

• Subjects with insomnia related to GAD.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Insomnia

Intervention

Drug:
• Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. J Clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in subjective sleep latency averaged over the double-blind treatment period.		8 weeks	No
Secondary	Change from baseline in subjective total sleep time averaged over the double blind treatment period.		8 weeks	No