Clinical trial NCT00616655: Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Official title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: Anxiety
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)
timeFrame: Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)
measure: Change in Individual Item Scores on HAM-A
timeFrame: Baseline, Weeks 2, 4, 6, 8
measure: Change From Baseline in Clinician Global Impression of Severity (CGI-S)
timeFrame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
measure: Clinical Global Impression- Improvement (CGI-I)
timeFrame: Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)
measure: Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response
timeFrame: Week 2, 4, 6, 8
measure: Hamilton Anxiety Scale (HAM-A) Remission
timeFrame: Week 2, 4, 6, 8 based on last observation carried forward (LOCF)
measure: Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form
timeFrame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
measure: Change From Baseline Insomnia Severity Index (ISI) Total Score
timeFrame: Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)
measure: Change From Baseline Sheehan Disability Scale (SDS)
timeFrame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
measure: Change From Baseline Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharaceutical Studies, Inc.
state: Alabama
city: Arcadia
country: United States
state: California
city: Beverly Hills
country: United States
facility: Southwestern Research, Inc.
state: California
city: Burbank
country: United States
facility: Southwestern Research, Inc.
state: California
city: Glendale
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Glendale
country: United States
facility: California clinical Trials Medical Group
state: California
city: Newport Beach
country: United States
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Paramount
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Pasadena
country: United States
facility: Southwestern Research, Inc.
state: California
city: San Diego
country: United States
facility: California clinical Trials Medical Group
state: California
city: Stanford
country: United States
facility: Stanford Universtiy Medical center
state: California
city: Farmington
country: United States
facility: University of CT Health Center
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care, PC
state: Connecticut
city: Bradenton
country: United States
facility: Florida Clinical Research Center LLC
state: Florida
city: Gainsville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: St. Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Georgia
city: Smyrna
country: United States
facility: Carmen Research
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Park Ridge
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Illinois
city: Overland Park
country: United States
facility: Vince and Associats Clinical Research
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Baltimore
country: United States
facility: Pharasite Research, Inc.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Braintree
country: United States
facility: Coastal Research Associates, Inc.
state: Massachusetts
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Clementon
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Fresh Meadows
country: United States
facility: Comprehensive NeuroScience, Inc.
state: New York
city: New York
country: United States
facility: Fieve Clinica Services, Inc.
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research, PC
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research, P.C.
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Raleigh
country: United States
facility: Glenwood Psychiatric Associates, P.L.L.C.
state: North Carolina
city: Bismarck
country: United States
facility: Horizon Medical Services
state: North Dakota
city: Beachwood
country: United States
facility: North Coast Clinical Trials
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sties, LLC
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Mdical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: East Providence
country: United States
facility: rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Houston
country: United States
facility: Carolos Guerra, Jr., M.D.
state: Texas
city: San Antonio
country: United States
facility: San Antonio Psychiatric Research Center
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia, Center for Psychiatric Clinical Research
state: Virginia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: CNS Medical Director
role: STUDY_DIRECTOR
References:
citation: Williams JB, Kobak KA, Giller E, Reasner DS, Curry L, Detke MJ. Comparison of Site-Based Versus Central Ratings in a Study of Generalized Anxiety Disorder. J Clin Psychopharmacol. 2015 Dec;35(6):654-60. doi: 10.1097/JCP.0000000000000422.