Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder - Full Text View

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00235508

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 IV

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Eszopiclone Escitalopram oxalate

U.S. FDA Resources

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

Show 64 Study Locations

Sponsors and Collaborators

Sunovion

More Information

Additional Information:

Lunesta Patient's Instructions for Use This link exits the ClinicalTrials.gov site

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):

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.

Responsible Party:	Executive Medical Director, Clinical Research, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00235508 History of Changes
Other Study ID Numbers:	190-902
Study First Received:	October 6, 2005
Last Updated:	January 11, 2011
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 February 09, 2012