Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
NCT ID: NCT00616655
Last Updated: 2016-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
456 participants
INTERVENTIONAL
2008-01-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
eszopiclone
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
2
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
eszopiclone
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
3
Placebo total daily dose 0.9 mg
Placebo
Placebo total daily dose 0.9 mg
Interventions
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eszopiclone
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
eszopiclone
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
Placebo
Placebo total daily dose 0.9 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have GAD
* Subjects must be in otherwise good general health
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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CNS Medical Director
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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Birmingham Psychiatry Pharaceutical Studies, Inc.
Birmingham, Alabama, United States
Arcadia, California, United States
Southwestern Research, Inc.
Beverly Hills, California, United States
Southwestern Research, Inc.
Burbank, California, United States
California Clinical Trials Medical Group
Glendale, California, United States
California clinical Trials Medical Group
Glendale, California, United States
Newport Beach, California, United States
Excell Research
Oceanside, California, United States
California Clinical Trials Medical Group
Paramount, California, United States
Southwestern Research, Inc.
Pasadena, California, United States
California clinical Trials Medical Group
San Diego, California, United States
Stanford Universtiy Medical center
Stanford, California, United States
University of CT Health Center
Farmington, Connecticut, United States
Comprehensive Psychiatric Care, PC
Norwich, Connecticut, United States
Florida Clinical Research Center LLC
Bradenton, Florida, United States
Sarkis Clinical Trials
Gainsville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, United States
Comprehensive NeuroScience, Inc.
Atlanta, Georgia, United States
Carmen Research
Smyrna, Georgia, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, United States
Comprehensive NeuroScience, Inc.
Park Ridge, Illinois, United States
Vince and Associats Clinical Research
Overland Park, Kansas, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Pedia Research, LLC
Owensboro, Kentucky, United States
Pharasite Research, Inc.
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Coastal Research Associates, Inc.
Braintree, Massachusetts, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
CRI Worldwide, LLC
Clementon, New Jersey, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Comprehensive NeuroScience, Inc.
Fresh Meadows, New York, United States
Fieve Clinica Services, Inc.
New York, New York, United States
Medical & Behavioral Health Research, PC
New York, New York, United States
Medical & Behavioral Health Research, P.C.
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Glenwood Psychiatric Associates, P.L.L.C.
Raleigh, North Carolina, United States
Horizon Medical Services
Bismarck, North Dakota, United States
North Coast Clinical Trials
Beachwood, Ohio, United States
Patient Priority Clinical Sties, LLC
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
North Star Mdical Research, LLC
Middleburg Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States
rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Future Search Trials
Austin, Texas, United States
Carolos Guerra, Jr., M.D.
Houston, Texas, United States
San Antonio Psychiatric Research Center
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
University of Virginia, Center for Psychiatric Clinical Research
Charlottesville, Virginia, United States
Countries
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References
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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.
Other Identifiers
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194-027
Identifier Type: -
Identifier Source: org_study_id
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