Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00235508
• Collaborator: (none)
• Enrollment: 420
• Locations: 64
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Generalized Anxiety Disorder	Drug: Eszopiclone (Lunesta)	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• 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.
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The change from baseline in subjective sleep latency averaged over the double-blind treatment period. [8 weeks]

Secondary Outcome Measures

1. Change from baseline in subjective total sleep time averaged over the double blind treatment period. [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Mesa	Arizona	United States
3		Scottsdale	Arizona	United States
4		Irvine	California	United States
5		La Mesa	California	United States
6		National City	California	United States
7		Oceanside	California	United States
8		Orange	California	United States
9		Pasadena	California	United States
10		Redlands	California	United States
11		Riverside	California	United States
12		San Diego	California	United States
13		Farmington	Connecticut	United States
14		Washington	District of Columbia	United States
15		Coral Springs	Florida	United States
16		Fort Lauderdale	Florida	United States
17		Gainesville	Florida	United States
18		Jacksonville	Florida	United States
19		Orlando	Florida	United States
20		Pembroke Pines	Florida	United States
21		St. Petersburg	Florida	United States
22		Atlanta	Georgia	United States
23		Augusta	Georgia	United States
24		Smyrna	Georgia	United States
25		Northfield	Illinois	United States
26		Indianapolis	Indiana	United States
27		Owensboro	Kentucky	United States
28		Baltimore	Maryland	United States
29		Rockville	Maryland	United States
30		Braintree	Massachusetts	United States
31		Brighton	Massachusetts	United States
32		Brockton	Massachusetts	United States
33		Cambridge	Massachusetts	United States
34		Watertown	Massachusetts	United States
35		St. Louis	Missouri	United States
36		Kenilworth	New Jersey	United States
37		Piscataway	New Jersey	United States
38		Brooklyn	New York	United States
39		Lawrence	New York	United States
40		New York	New York	United States
41		Durham	North Carolina	United States
42		Raleigh	North Carolina	United States
43		Winston-Salem	North Carolina	United States
44		Bismarck	North Dakota	United States
45		Beachwood	Ohio	United States
46		Cincinnati	Ohio	United States
47		Dayton	Ohio	United States
48		Middleburg Heights	Ohio	United States
49		Eugene	Oregon	United States
50		Portland	Oregon	United States
51		Salem	Oregon	United States
52		Moon Township	Pennsylvania	United States
53		Philadelphia	Pennsylvania	United States
54		Scotland	Pennsylvania	United States
55		Columbia	South Carolina	United States
56		Memphis	Tennessee	United States
57		Austin	Texas	United States
58		Houston	Texas	United States
59		Richardson	Texas	United States
60		San Antonio	Texas	United States
61		Wichita Falls	Texas	United States
62		Falls Church	Virginia	United States
63		Richmond	Virginia	United States
64		Middleton	Wisconsin	United States

Sponsors and Collaborators

• Sunovion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT00235508
• Other Study ID Numbers: 190-902
• First Posted: Oct 10, 2005
• Last Update Posted: Feb 22, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Sunovion: Insomnia; Anxiety; Generalized Anxiety Disorder
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Disease; Anxiety Disorders; Eszopiclone

Study Results

No Results Posted as of Feb 22, 2012