Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sunovion

ClinicalTrials.gov Identifier:

NCT00235508

First received: October 6, 2005

Last updated: February 21, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2005
Last Updated Date	February 21, 2012
Start Date ^ICMJE	June 2005
Primary Completion Date	April 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2007)	The change from baseline in subjective sleep latency averaged over the double-blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00235508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2007)	Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
Official Title ^ICMJE	The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
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.
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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Insomnia Generalized Anxiety Disorder
Intervention ^ICMJE	Drug: Eszopiclone (Lunesta) Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime Other Name: Lunesta
Study Arm (s)	Active Comparator: 1 Escitalopram oxalate 10 mg at bedtime Intervention: Drug: Eszopiclone (Lunesta) Active Comparator: 2 Eszopiclone 3 mg at bedtime Intervention: Drug: Eszopiclone (Lunesta)
Publications *	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 Pollack M, Kinrys G, Krystal A, McCall WV, Roth T, Schaefer K, Rubens R, Roach J, Huang H, Krishnan R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008 May;65(5):551-62.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	420
Completion Date	April 2006
Primary Completion Date	April 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Subjects, between the ages of 18 and 64 years inclusive Subjects with Generalized Anxiety Disorder (GAD) Subjects with insomnia related to GAD.
Gender	Both
Ages	18 Years to 64 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00235508
Other Study ID Numbers ^ICMJE	190-902
Has Data Monitoring Committee	No
Responsible Party	Sunovion
Study Sponsor ^ICMJE	Sunovion
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sunovion
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top