Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
This study has been completed.
Sponsor:
Sunovion
Information provided by (Responsible Party):
Sunovion
ClinicalTrials.gov Identifier:
NCT00235508
First received: October 6, 2005
Last updated: February 21, 2012
Last verified: February 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Insomnia Generalized Anxiety Disorder |
Drug: Eszopiclone (Lunesta) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder. |
Resource links provided by NLM:
Further study details as provided by Sunovion:
Primary Outcome Measures:
- The change from baseline in subjective sleep latency averaged over the double-blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 420 |
| Study Start Date: | June 2005 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Escitalopram oxalate 10 mg at bedtime
|
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta
|
|
Active Comparator: 2
Eszopiclone 3 mg at bedtime
|
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta
|
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| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235508
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| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Mesa, Arizona, United States | |
| Scottsdale, Arizona, United States | |
| United States, California | |
| Irvine, California, United States | |
| La Mesa, California, United States | |
| National City, California, United States | |
| Oceanside, California, United States | |
| Orange, California, United States | |
| Pasadena, California, United States | |
| Redlands, California, United States | |
| Riverside, California, United States | |
| San Diego, California, United States | |
| United States, Connecticut | |
| Farmington, Connecticut, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Coral Springs, Florida, United States | |
| Fort Lauderdale, Florida, United States | |
| Gainesville, Florida, United States | |
| Jacksonville, Florida, United States | |
| Orlando, Florida, United States | |
| Pembroke Pines, Florida, United States | |
| St. Petersburg, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Augusta, Georgia, United States | |
| Smyrna, Georgia, United States | |
| United States, Illinois | |
| Northfield, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| United States, Kentucky | |
| Owensboro, Kentucky, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| Rockville, Maryland, United States | |
| United States, Massachusetts | |
| Braintree, Massachusetts, United States | |
| Brighton, Massachusetts, United States | |
| Brockton, Massachusetts, United States | |
| Cambridge, Massachusetts, United States | |
| Watertown, Massachusetts, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Kenilworth, New Jersey, United States | |
| Piscataway, New Jersey, United States | |
| United States, New York | |
| Brooklyn, New York, United States | |
| Lawrence, New York, United States | |
| New York, New York, United States | |
| United States, North Carolina | |
| Durham, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| United States, North Dakota | |
| Bismarck, North Dakota, United States | |
| United States, Ohio | |
| Beachwood, Ohio, United States | |
| Cincinnati, Ohio, United States | |
| Dayton, Ohio, United States | |
| Middleburg Heights, Ohio, United States | |
| United States, Oregon | |
| Eugene, Oregon, United States | |
| Portland, Oregon, United States | |
| Salem, Oregon, United States | |
| United States, Pennsylvania | |
| Moon Township, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| Scotland, Pennsylvania, United States | |
| United States, South Carolina | |
| Columbia, South Carolina, United States | |
| United States, Tennessee | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Austin, Texas, United States | |
| Houston, Texas, United States | |
| Richardson, Texas, United States | |
| San Antonio, Texas, United States | |
| Wichita Falls, Texas, United States | |
| United States, Virginia | |
| Falls Church, Virginia, United States | |
| Richmond, Virginia, United States | |
| United States, Wisconsin | |
| Middleton, Wisconsin, United States | |
Sponsors and Collaborators
Sunovion
More Information
Additional Information:
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
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sunovion |
| ClinicalTrials.gov Identifier: | NCT00235508 History of Changes |
| Other Study ID Numbers: | 190-902 |
| Study First Received: | October 6, 2005 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sunovion:
|
Insomnia Anxiety Generalized Anxiety Disorder |
Additional relevant MeSH terms:
|
Anxiety Disorders Sleep Initiation and Maintenance Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Dexetimide Citalopram Eszopiclone Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on May 23, 2013