Clinical trial NCT00235508: Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
Official title: The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Generalized Anxiety Disorder
Keywords: Insomnia
Anxiety
Generalized Anxiety Disorder
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change from baseline in subjective sleep latency averaged over the double-blind treatment period.
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in subjective total sleep time averaged over the double blind treatment period.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Irvine
country: United States
state: California
city: La Mesa
country: United States
state: California
city: National City
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Redlands
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Coral Springs
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Northfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Owensboro
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Braintree
country: United States
state: Massachusetts
city: Brighton
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Cambridge
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Kenilworth
country: United States
state: New Jersey
city: Piscataway
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Lawrence
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Beachwood
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Moon Township
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scotland
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Richardson
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Middleton
country: United States
state: Wisconsin
Study officials:
References:
citation: 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 Psychiatry. 2011 Apr;72(4):473-9. doi: 10.4088/JCP.09m05131gry. Epub 2010 Nov 2.
citation: 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. doi: 10.1001/archpsyc.65.5.551.