Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects - Full Text View

Purpose

To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: eszopiclone Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

Change in HAM-A Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in HAM-A [ Time Frame: Day 0, Weeks 2, 4, 6 , 9 ] [ Designated as safety issue: Yes ]
Change in individual item scores on HAM-A [ Time Frame: Day 0, Weeks 2, 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
Change in CGI-S [ Time Frame: Day 0, Weeks 2, 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
CGI-I [ Time Frame: Weeks 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
Time to onset of HAM-A response [ Time Frame: Day 0, Week 2, 4, 6, 8,9 ] [ Designated as safety issue: Yes ]
Time to onset of remission [ Time Frame: Day 0, Week 2, 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
Change in QLESQ Short Form [ Time Frame: Day 0, Weeks 2, 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
Change in ISI total score [ Time Frame: Day 0, Weeks 2, 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
Change in SDS [ Time Frame: Day 0, Weeks 2, 4, 6, 8, 9 ] [ Designated as safety issue: Yes ]
Change in ESS [ Time Frame: Day 0, Weeks 2, 4, 6, 8,9 ] [ Designated as safety issue: Yes ]

Enrollment:	507
Study Start Date:	January 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 SEP-225441 (eszopiclone) total daily dose of 1.5 mg	Drug: eszopiclone SEP-225441 (eszopiclone) total daily dose of 1.5 mg Other Name: SEP-225441
Active Comparator: 2 SEP-225441 (eszopiclone) total daily dose of 0.9 mg	Drug: eszopiclone SEP-225441 (eszopiclone) total daily dose of 0.9 mg Other Name: SEP-225441
Placebo Comparator: 3 Placebo total daily dose 0.9 mg	Drug: Placebo Placebo total daily dose 0.9 mg Other Name: Placebo

Detailed Description:

This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. 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 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects must be between 18 and 50 years of age
Subjects must have GAD
Subjects must be in otherwise good general health

Exclusion Criteria:

Subject has a documented history of HIV, hepatitis B or hepatitis C.
Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.
Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.
Subject has presence or history of antisocial personality or other severe disorder
Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).
Subject has history of seizures, including febrile seizures.
Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.
Subject is undergoing or has undergone electroconvulsive therapy.
Subject is a current smoker or has smoked within the last 12 months.
Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616655

Show 56 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

CNS Medical Director

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00616655 History of Changes
Other Study ID Numbers:	194-027
Study First Received:	February 4, 2008
Last Updated:	May 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Anxiety

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013